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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
PT003 MDI Cardiovascular Safety Study
Study identifier:PT003003
ClinicalTrials.gov identifier:NCT01349803
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
PT005 MDI, PT001 MDI, PT003 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Sex
All
Actual Enrollment
237
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 01 May 2011
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2019 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
Location
Pearl Investigative Site
Livonia, Michigan, United States
Location
Pearl Investigative Site
Fullerton, California, United States
Location
Pearl Investigative Site
North Dartmouth, Massachusetts, United States
Location
Pearl Investigative Site
San Diego, California, United States
Location
Pearl Investigative Site
Lafayette, Louisiana, United States
Location
Pearl Investigative Site
San Antonio, Texas, United States
Location
Pearl Investigative Site
Medford, Oregon, United States
Location
Pearl Investigative Site
Glendale, Arizona, United States
| Arms | Assigned Interventions |
|---|---|
| Experimental: PT005 MDI PT005 MDI | Drug: PT005 MDI PT005 MDI administered as two puffs BID for 14 days |
| Experimental: PT001 MDI PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 14 days |
| Experimental: PT003 MDI PT003 MDI | Drug: PT003 MDI PT003 MDI administered as two puffs BID for 14 days |
| Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol Fumarate 12 μg (Foradil® Aerolizer®) | Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days Other Name: Foradil® Aerolizer® |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Conducted at 15 sites throughout the US, Australia, and New Zealand from May 2011 - November 2011. Study participation was a maximum of 7 weeks. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Study was a multicenter, randomized, double-blind, parallel group, chronic dosing (14 days) study; each patient was randomized to receive 1 of 4 possible treatments over the course of a 14-day treatment period |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Participant Flow: Overall Study
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
| STARTED | 60 | 58 | 60 | 59 |
| COMPLETED | 59 | 57 | 57 | 57 |
| NOT COMPLETED | 1 | 1 | 3 | 2 |
| Adverse Event | 0 | 0 | 0 | 2 |
| Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Protocol-specified criteria | 0 | 1 | 3 | 0 |
Baseline Characteristics
Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Safety Population (all randomized subjects)
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Baseline Measures
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: Participants] |
60 | 58 | 60 | 59 | 237 |
| Age Continuous [units: Years] Mean ± Standard Deviation |
64.1 ± 8.13 | 63.3 ± 7.93 | 64.3 ± 7.38 | 64.1 ± 7.91 | 64.0 ± 7.80 |
| Sex: Female, Male [units: ] |
|||||
| Female | 33 | 32 | 26 | 31 | 122 |
| Male | 27 | 26 | 34 | 28 | 115 |
Outcome Measures
1. Primary Outcome Measure: Change from Baseline in 24-Hour Mean Heart Rate Post-dose [ Time Frame: 14 days ]
| Measure Type | Primary |
|---|---|
| Measure Name | Change from Baseline in 24-Hour Mean Heart Rate Post-dose |
| Measure Description | The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD). |
| Time Frame | 14 days |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
59 | 57 | 55 | 55 |
| Change from Baseline in 24-Hour Mean Heart Rate Post-dose [units: bpm] Least Squares Mean (95% Confidence Interval) |
-0.19 (-1.38 to 1.00) | -1.84 (-3.05 to -0.63) | 0.40 (-0.84 to 1.63) | -0.09 (-1.32 to 1.15) |
No statistical analysis provided for Change from Baseline in 24-Hour Mean Heart Rate Post-dose
2. Secondary Outcome Measure: Change from Baseline in Mean FEV1 Trough [ Time Frame: Day 7 to Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in Mean FEV1 Trough |
| Measure Description | Trough FEV1 averaged over Day 7 and Day 14 |
| Time Frame | Day 7 to Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| MITT - patients from the ITT population who completed at least one evaluable FEV1 spirometry assessment for baseline (pre-dose on Day 1) and had an evaluable FEV1 spirometry assessment on at least one of the following: Day 7 pre-dose or Day 14 pre-dose (or both). |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
57 | 49 | 53 | 55 |
| Change from Baseline in Mean FEV1 Trough [units: Liters] Least Squares Mean (95% Confidence Interval) |
0.091 (0.049 to 0.134) | 0.126 (0.080 to 0.172) | 0.251 (0.207 to 0.295) | 0.124 (0.081 to 0.167) |
No statistical analysis provided for Change from Baseline in Mean FEV1 Trough
3. Secondary Outcome Measure: Change from Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment [ Time Frame: 24 hours ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | 24 hours |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment [units: bpm] Least Squares Mean (95% Confidence Interval) |
0.56 (-0.73 to 1.85) | -0.44 (-1.75 to 0.87) | 0.92 (-0.40 to 2.24) | 0.31 (-1.01 to 1.63) |
No statistical analysis provided for Change from Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment
4. Secondary Outcome Measure: Change from Baseline in Daytime Mean Heart Rate [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in Daytime Mean Heart Rate |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=59 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
59 | 58 | 57 | 57 |
| Change from Baseline in Daytime Mean Heart Rate [units: bpm] Least Squares Mean (95% Confidence Interval) |
||||
| Day 1 | 0.00 (-1.40 to 1.40) | -0.52 (-1.93 to 0.90) | 0.16 (-1.27 to 1.58) | -0.17 (-1.60 to 1.25) |
| Day 14 | -1.22 (-2.64 to 0.20) | -2.00 (-3.45 to -0.56) | -0.40 (-1.87 to 1.07) | -0.54 (-2.01 to 0.93) |
No statistical analysis provided for Change from Baseline in Daytime Mean Heart Rate
5. Secondary Outcome Measure: Change from Baseline in Night Time Mean Heart Rate [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in Night Time Mean Heart Rate |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=59 Day 14: N=58 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=57 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=55 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
59 | 57 | 55 | 57 |
| Change from Baseline in Night Time Mean Heart Rate [units: bpm] Least Squares Mean (95% Confidence Interval) |
||||
| Day 1 | 3.05 (1.63 to 4.47) | -0.54 (-1.99 to 0.90) | 2.95 (1.48 to 4.42) | 0.70 (-0.74 to 2.15) |
| Day 14 | 0.04 (-1.94 to 2.03) | -0.88 (-2.89 to 1.12) | 0.11 (-1.93 to 2.15) | 1.05 (-0.99 to 3.09) |
No statistical analysis provided for Change from Baseline in Night Time Mean Heart Rate
6. Secondary Outcome Measure: Change from Baseline in 24-Hour Maximum Heart Rate [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in 24-Hour Maximum Heart Rate |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in 24-Hour Maximum Heart Rate [units: bpm] Least Squares Mean (95% Confidence Interval) |
||||
| Day 1 | -4.71 (-8.72 to -0.69) | -1.88 (-5.96 to 2.20) | -1.91 (-6.03 to 2.21) | 0.31 (-3.81 to 4.42) |
| Day 14 | 0.75 (-3.46 to 4.97) | -2.21 (-6.50 to 2.07) | -0.06 (-4.42 to 4.31) | -1.13 (-5.49 to 3.23) |
No statistical analysis provided for Change from Baseline in 24-Hour Maximum Heart Rate
7. Secondary Outcome Measure: Change from Baseline in 24-Hour Minimum Heart Rate [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in 24-Hour Minimum Heart Rate |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in 24-Hour Minimum Heart Rate [units: bpm] Least Squares Mean (95% Confidence Interval) |
||||
| Day 1 | 0.05 (-1.19 to 1.29) | -0.03 (-1.30 to 1.23) | 0.50 (-0.78 to 1.78) | 0.45 (-0.82 to 1.72) |
| Day 14 | -0.79 (-1.92 to 0.35) | -1.92 (-3.07 to -0.77) | -0.21 (-1.38 to 0.97) | 0.88 (-0.30 to 2.05) |
No statistical analysis provided for Change from Baseline in 24-Hour Minimum Heart Rate
8. Secondary Outcome Measure: Change from Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring [units: Ventricular events / hour] Mean (Standard Error) |
||||
| Day 1 | 1.31 (1.605) | 0.56 (0.853) | 1.59 (1.879) | 0.45 (0.580) |
| Day 14 | 3.09 (4.092) | 0.62 (1.088) | -0.10 (0.541) | -0.54 (0.424) |
No statistical analysis provided for Change from Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring
9. Secondary Outcome Measure: Change from Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring [units: Ventricular couplets / hour] Mean (Standard Error) |
||||
| Day 1 | 0.09 (0.071) | 0.00 (0.005) | 0.00 (0.009) | 0.00 (0.005) |
| Day 14 | 0.02 (0.021) | 0.00 (0.009) | -0.03 (0.033) | -0.01 (0.004) |
No statistical analysis provided for Change from Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring
10. Secondary Outcome Measure: Change from Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring [units: Ventricular runs / hour] Mean (Standard Error) |
||||
| Day 1 | -0.003 (0.0024) | -0.001 (0.0017) | 0.001 (0.0019) | -0.003 (0.0040) |
| Day 14 | -0.004 (0.0021) | 0.001 (0.0029) | 0.001 (0.0013) | -0.004 (0.0037) |
No statistical analysis provided for Change from Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring
11. Secondary Outcome Measure: Change from Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring [units: Supraventricular events / hour] Mean (Standard Error) |
||||
| Day 1 | 7.72 (6.971) | 0.74 (0.804) | -4.55 (5.947) | 15.36 (16.359) |
| Day 14 | 3.61 (5.179) | -9.29 (9.398) | 3.61 (5.179) | 5.81 (11.320) |
No statistical analysis provided for Change from Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring
12. Secondary Outcome Measure: Change from Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring [units: Supraventricular couplets / hour] Mean (Standard Error) |
||||
| Day 1 | 0.03 (0.034) | 0.01 (0.021) | 0.05 (0.019) | 0.04 (0.065) |
| Day 14 | 0.01 (0.025) | 0.00 (0.017) | 0.00 (0.018) | -0.02 (0.020) |
No statistical analysis provided for Change from Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring
13. Secondary Outcome Measure: Change from Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring [units: Supraventricular runs / hour] Mean (Standard Error) |
||||
| Day 1 | 0.00 (0.014) | 0.02 (0.011) | 0.01 (0.011) | 0.01 (0.010) |
| Day 14 | 0.01 (0.013) | 0.02 (0.015) | 0.00 (0.012) | 0.01 (0.014) |
No statistical analysis provided for Change from Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring
14. Secondary Outcome Measure: Change from Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring [units: Bradycardia episodes / hour] Mean (Standard Error) |
||||
| Day 1 | -0.04 (0.139) | -0.02 (0.083) | 0.11 (0.193) | 0.03 (0.036) |
| Day 14 | -0.02 (0.111) | 0.40 (0.210) | 0.27 (0.283) | 0.13 (0.132) |
No statistical analysis provided for Change from Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring
15. Secondary Outcome Measure: Change from Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring [ Time Frame: Baseline, Day 1, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Change from Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg
Day 1: N=60 Day 14: N=59 |
| GP MDI (PT001) | GP MDI 36 mcg
Day 1: N=58 Day 14: N=57 |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg
Day 1: N=57 Day 14: N=55 |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg
Day 1: N=57 Day 14: N=55 |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 57 | 57 |
| Change from Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring [units: Tachycardia episodes / hour] Mean (Standard Error) |
||||
| Day 1 | -0.16 (0.170) | -0.24 (0.209) | -0.02 (0.160) | -0.09 (0.197) |
| Day 14 | -0.23 (0.146) | -0.34 (0.229) | 0.22 (0.154) | -0.01 (0.206) |
No statistical analysis provided for Change from Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring
16. Secondary Outcome Measure: Mean Change from Baseline in QTcF Interval [ Time Frame: Baseline, Day 1, Day 7, and Day 14 ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Mean Change from Baseline in QTcF Interval |
| Measure Description | The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). |
| Time Frame | Baseline, Day 1, Day 7, and Day 14 |
| Safety Issue? | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Safety Population |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Measured Values
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | |
|---|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
60 | 58 | 60 | 59 |
| Mean Change from Baseline in QTcF Interval [units: msec] Mean (Standard Deviation) |
||||
| Day 1: Post-dose 30 minutes | 1.53 (11.238) | 4.67 (12.548) | 3.27 (9.223) | 3.71 (9.816) |
| Day 1: Post-dose 2 hours | 1.75 (13.861) | 3.57 (12.866) | 1.62 (13.785) | 5.25 (11.709) |
| Day 1: Post-dose 24 hours | -0.09 (13.309) | 1.23 (16.142) | -1.43 (12.724) | 0.36 (10.989) |
| Day 7: Pre-dose | -1.80 (10.362) | 1.40 (14.713) | 1.06 (12.151) | 3.85 (12.599) |
| Day 14: Pre-dose | -0.59 (12.523) | 1.79 (13.028) | -0.42 (11.910) | 1.53 (14.085) |
| Day 14: Post-dose 30 minutes | 1.21 (13.350) | 4.10 (17.202) | 2.23 (13.194) | 1.20 (14.458) |
| Day 14: Post-dose 2 hours | 0.44 (12.521) | 6.02 (16.774) | 5.01 (14.861) | 3.98 (14.135) |
| Day 14: Post-dose 24 hours | -1.32 (12.738) | -0.05 (13.794) | -1.93 (11.269) | 1.44 (16.086) |
No statistical analysis provided for Mean Change from Baseline in QTcF Interval
Serious Adverse Events
| Time Frame | Adverse events (AEs) and Serious Adverse Events (SAEs) were collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug. |
|---|---|
| Additional Description | All patients who were randomized to a treatment, received at least one dose of the study treatment, and had any safety data after starting study treatment. A patient who used a study treatment, but took less than one full dose qualified for this population. |
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Serious Adverse Events
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Total, serious adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 1/60 (1.67%) | 0/58 (0.00%) | 1/60 (1.67%) | 1/59 (1.69%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Chronic obstructive pulmonary disease1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 1/60 (1.67%) | 0/58 (0.00%) | 1/60 (1.67%) | 1/59 (1.69%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # events | 1 | 0 | 1 | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Other Adverse Events
| Time Frame | Adverse events (AEs) and Serious Adverse Events (SAEs) were collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug. |
|---|---|
| Additional Description | All patients who were randomized to a treatment, received at least one dose of the study treatment, and had any safety data after starting study treatment. A patient who used a study treatment, but took less than one full dose qualified for this population. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| FF MDI (PT005) | FF MDI 9.6 mcg |
| GP MDI (PT001) | GP MDI 36 mcg |
| GFF MDI (PT003) | GFF MDI 36/9.6 mcg |
| Foradil® Aerolizer® | Formoterol Fumarate 12 μg |
Other Adverse Events
| FF MDI (PT005) | GP MDI (PT001) | GFF MDI (PT003) | Foradil® Aerolizer® | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total, other (not including serious) adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 6/60 (10.00%) | 4/58 (6.90%) | 2/60 (3.33%) | 5/59 (8.47%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Respiratory, thoracic and mediastinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cough1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 2/60 (3.33%) | 3/58 (5.17%) | 0/60 (0.00%) | 1/59 (1.69%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # events | 2 | 3 | 0 | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Infections and infestations | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nasopharyngitis1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 0/60 (0.00%) | 1/58 (1.72%) | 1/60 (1.67%) | 3/59 (5.08%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # events | 0 | 1 | 1 | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nervous system disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Tremor1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 4/60 (6.67%) | 0/58 (0.00%) | 1/60 (1.67%) | 1/59 (1.69%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # events | 5 | 0 | 1 | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Certain Agreements
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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Results Point of Contact
| Name/Title: | Colin Reisner, MD, FCCP, FAAAAI |
| Organization: | Pearl Therapeutics, Inc |
| Phone | 973-975-0320 |
| E-mail: | [email protected] |
Contacts
Investigators
Principal Investigator
Colin Reisner
Pearl Therapeutics
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hOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
