PT001 MDI versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study identifier:PT001002

ClinicalTrials.gov identifier:NCT01350128

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 2

Healthy volunteers

Study drug

PT001 MDI, Ipratropium Bromide HFA Inhalation Aerosol

Sex

All

Actual Enrollment

103

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 May 2011

Primary Completion Date: 01 Oct 2011

Study Completion Date: 01 Oct 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2018 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

Location

Pearl Investigative Site

Medford, Oregon, United States

Location

Pearl Investigative Site

Charlotte, North Carolina, United States

Location

Pearl Investigative Site

Summit, New Jersey, United States

Location

Pearl Investigative Site

Panama City, Florida, United States

Location

Pearl Investigative Site

Winter Park, Florida, United States

Location

Pearl Investigative Site

Cherry Hill, New Jersey, United States

Location

Pearl Investigative Site

Richmond, Virginia, United States

Location

Pearl Investigative Site

Longview, Texas, United States

Arms	Assigned Interventions
Experimental: PT001 MDI (Dose 1) PT001 MDI	Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days
Experimental: PT001 MDI (Dose 2) PT001 MDI	Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days
Experimental: PT001 MDI (Dose 3) PT001 MDI	Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days
Experimental: PT001 MDI (Dose 4) PT001 MDI	Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days
Active Comparator: Ipratropium Bromide HFA Inhalation Aerosol Ipratropium Bromide HFA Inhalation Aerosol	Drug: Ipratropium Bromide HFA Inhalation Aerosol Taken as 2 inhalations of the 17 µg per actuation strength MDI QID Other Name: Atrovent
Placebo Comparator: Placebo MDI PT001 Placebo MDI	Other: Placebo MDI Matching placebo to PT001 MDI administered as two puffs BID for 7 days

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 9 US sites from May-October 2011. Entire period of study participation per subject was a maximum of 15 weeks. Planned target enrollment of 84 subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a chronic dosing study (7 days), 3-period, 6-treatment, incomplete block, crossover study. Each subject received 3 of 6 possible treatments; each treatment period was separated by a washout period 7-28 days. By-treatment sequence tabulations of the data were not pre-specified.

Reporting Groups

	Description
All Subjects Randomized

Participant Flow: Overall Study

	All Subjects Randomized
STARTED	103
GP MDI 36 µg BID	49^[1]
GP MDI 18 µg BID	49
GP MDI 9 µg BID	49
GP MDI 4.6 µg BID	45
Placebo MDI BID	48
Atrovent HFA 34 µg BID	48
COMPLETED	89
NOT COMPLETED	14
Withdrawal by Subject	3
Protocol discontinuation criteria	8
Physician Decision	1
Lost to Follow-up	2

[1]	Glycopyrronium Metered Dose Inhaler

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Intent-to-Treat (ITT) Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.

Reporting Groups

	Description
ITT Population	ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.

Baseline Measures

	ITT Population
Number of Participants [units: Participants]	103
Age Continuous [units: years] Mean ± Standard Deviation	61.2 ± 8.19
Gender, Male/Female [units: Participants]
Female	48
Male	55

Outcome Measures

1. Primary Outcome Measure: FEV1 AUC0-12 [ Time Frame: Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours) ]

Measure Type	Primary
Measure Name	FEV1 AUC0-12
Measure Description	FEV1 AUC0-12 following chronic dosing (1 week), normalized.
Time Frame	Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Safety Issue?	No

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.
Modified Intent to Treat (MITT) Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	40	41	41	39	42	40
FEV1 AUC0-12 [units: Liter] Least Squares Mean (95% Confidence Interval)	1.477 (1.418 to 1.537)	1.497 (1.437 to 1.556)	1.443 (1.385 to 1.501)	1.514 (1.456 to 1.572)	1.465 (1.405 to 1.524)	1.323 (1.263 to 1.382)

No statistical analysis provided for FEV1 AUC0-12

2. Secondary Outcome Measure: Peak change from baseline in FEV1 on Day 1 [ Time Frame: Day 1 ]

Measure Type	Secondary
Measure Name	Peak change from baseline in FEV1 on Day 1
Measure Description	Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)
Time Frame	Day 1
Safety Issue?	No

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 Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	45	46	44	41	44	46
Peak change from baseline in FEV1 on Day 1 [units: Liter] Least Squares Mean (95% Confidence Interval)	0.245 (0.195 to 0.295)	0.221 (0.172 to 0.270)	0.181 (0.130 to 0.232)	0.204 (0.153 to 0.255)	0.250 (0.198 to 0.301)	0.071 (0.021 to 0.120)

No statistical analysis provided for Peak change from baseline in FEV1 on Day 1

3. Secondary Outcome Measure: Time to onset of action ( ≥10% improvement in FEV1) on Day 1 [ Time Frame: Day 1 (15 min, 30 min, 1 hour, 2 hours) ]

Measure Type	Secondary
Measure Name	Time to onset of action ( ≥10% improvement in FEV1) on Day 1
Measure Description	Time to onset of action ( ≥10% improvement in FEV1)
Time Frame	Day 1 (15 min, 30 min, 1 hour, 2 hours)
Safety Issue?	No

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 Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	44	45	43	40	44	45
Time to onset of action ( ≥10% improvement in FEV1) on Day 1 [units: % of subjects]
15 minutes	32	31	19	25	48	7
30 minutes	32	18	7	20	25	9
1 hour	5	11	23	8	9	4
2 hours	2	13	14	15	2	13
No onset within 2 hours	30	27	37	33	16	67

No statistical analysis provided for Time to onset of action ( ≥10% improvement in FEV1) on Day 1

4. Secondary Outcome Measure: Proportion of subjects achieving at least 12% improvement in FEV1 on Day 1 [ Time Frame: Day 1 ]

Measure Type	Secondary
Measure Name	Proportion of subjects achieving at least 12% improvement in FEV1 on Day 1
Measure Description	Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)
Time Frame	Day 1
Safety Issue?	No

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 Population: This includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	45	46	44	41	45	46
Proportion of subjects achieving at least 12% improvement in FEV1 on Day 1 [units: Percent]	66.67	58.70	52.27	60.98	77.78	17.39

No statistical analysis provided for Proportion of subjects achieving at least 12% improvement in FEV1 on Day 1

5. Secondary Outcome Measure: Peak change from baseline in IC on Day 1 [ Time Frame: Day 1 ]

Measure Type	Secondary
Measure Name	Peak change from baseline in IC on Day 1
Measure Description	Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)
Time Frame	Day 1
Safety Issue?	No

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 Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	45	45	44	41	45	46
Peak change from baseline in IC on Day 1 [units: Liter] Least Squares Mean (95% Confidence Interval)	0.240 (0.165 to 0.316)	0.276 (0.201 to 0.351)	0.185 (0.111 to 0.259)	0.187 (0.111 to 0.262)	0.252 (0.173 to 0.330)	0.040 (-0.036 to 0.117)

No statistical analysis provided for Peak change from baseline in IC on Day 1

6. Secondary Outcome Measure: Change from baseline in morning pre-dose FEV1 on Day 7 [ Time Frame: Day 7 ]

Measure Type	Secondary
Measure Name	Change from baseline in morning pre-dose FEV1 on Day 7
Measure Description	Change from baseline in morning pre-dose FEV1
Time Frame	Day 7
Safety Issue?	No

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 Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	45	45	43	41	43	46
Change from baseline in morning pre-dose FEV1 on Day 7 [units: Liter] Least Squares Mean (95% Confidence Interval)	0.088 (0.039 to 0.136)	0.075 (0.027 to 0.124)	0.010 (-0.039 to 0.059)	0.084 (0.035 to 0.133)	-0.088 (-0.138 to -0.037)	-0.043 (-0.092 to 0.006)

No statistical analysis provided for Change from baseline in morning pre-dose FEV1 on Day 7

7. Secondary Outcome Measure: Peak change from baseline in FEV1 on Day 7 [ Time Frame: Day 7 ]

Measure Type	Secondary
Measure Name	Peak change from baseline in FEV1 on Day 7
Measure Description	Peak change from baseline in FEV1
Time Frame	Day 7
Safety Issue?	No

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 Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	45	45	43	41	43	44
Peak change from baseline in FEV1 on Day 7 [units: Liter] Least Squares Mean (95% Confidence Interval)	0.242 (0.181 to 0.302)	0.224 (0.164 to 0.284)	0.223 (0.162 to 0.285)	0.238 (0.176 to 0.300)	0.225 (0.164 to 0.287)	0.070 (0.009 to 0.131)

No statistical analysis provided for Peak change from baseline in FEV1 on Day 7

8. Secondary Outcome Measure: Peak change from baseline in IC on Day 7 [ Time Frame: Day 7 ]

Measure Type	Secondary
Measure Name	Peak change from baseline in IC on Day 7
Measure Description	Peak change from baseline in IC
Time Frame	Day 7
Safety Issue?	No

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 Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	45	45	43	41	43	44
Peak change from baseline in IC on Day 7 [units: Liters] Least Squares Mean (95% Confidence Interval)	0.213 (0.130 to 0.295)	0.189 (0.107 to 0.271)	0.161 (0.077 to 0.245)	0.192 (0.107 to 0.277)	0.191 (0.106 to 0.275)	-0.029 (-0.112 to 0.055)

No statistical analysis provided for Peak change from baseline in IC on Day 7

9. Secondary Outcome Measure: Change from baseline in 12-hour post-dose trough FEV1 on Day 7 [ Time Frame: Day 7 ]

Measure Type	Secondary
Measure Name	Change from baseline in 12-hour post-dose trough FEV1 on Day 7
Measure Description	Change from baseline in 12-hour post-dose trough FEV1
Time Frame	Day 7
Safety Issue?	No

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 Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo MDI BID	Placebo MDI BID.

Measured Values

	PT001 MDI 36 µg BID	PT001 MDI 18 µg BID	PT001 MDI 9 µg BID	PT001 MDI 4.6 µg BID	Ipratropium Bromide HFA Inhalation Aerosol	Placebo MDI BID
Number of Participants Analyzed [units:participants]	40	41	41	39	42	41
Change from baseline in 12-hour post-dose trough FEV1 on Day 7 [units: Liters] Least Squares Mean (95% Confidence Interval)	0.018 (-0.045 to 0.080)	0.079 (0.018 to 0.139)	0.004 (-0.057 to 0.065)	0.077 (0.016 to 0.139)	-0.041 (-0.103 to 0.021)	-0.054 (-0.117 to 0.009)

No statistical analysis provided for Change from baseline in 12-hour post-dose trough FEV1 on Day 7

Serious Adverse Events

Time Frame	Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
Additional Description	Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo BID	Placebo BID.

Serious Adverse Events

PT001 MDI 36 µg BID

PT001 MDI 18 µg BID

PT001 MDI 9 µg BID

PT001 MDI 4.6 µg BID

Ipratropium Bromide HFA Inhalation Aerosol

Placebo BID

Total, serious adverse events

# participants affected / at risk

0/49 (0.00%)

1/45 (2.22%)

1/48 (2.08%)

0/48 (0.00%)

Respiratory, thoracic and mediastinal disorders

COPD Exacerbation¹,^†

# participants affected / at risk

0/49 (0.00%)

1/45 (2.22%)

0/48 (0.00%)

# events

Vascular disorders

Deep Vein Thrombosis¹

# participants affected / at risk

0/49 (0.00%)

0/45 (0.00%)

1/48 (2.08%)

0/48 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA

Other Adverse Events

Time Frame	Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
Additional Description	Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
PT001 MDI 36 µg BID	PT001 MDI 36 µg BID.
PT001 MDI 18 µg BID	PT001 MDI 18 µg BID.
PT001 MDI 9 µg BID	PT001 MDI 9 µg BID
PT001 MDI 4.6 µg BID	PT001 MDI 4.6 µg BID.
Ipratropium Bromide HFA Inhalation Aerosol	Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
Placebo BID	Placebo BID.

Other Adverse Events

PT001 MDI 36 µg BID

PT001 MDI 18 µg BID

PT001 MDI 9 µg BID

PT001 MDI 4.6 µg BID

Ipratropium Bromide HFA Inhalation Aerosol

Placebo BID

Total, other (not including serious) adverse events

# participants affected / at risk

1/49 (2.04%)

2/49 (4.08%)

4/49 (8.16%)

4/45 (8.89%)

3/48 (6.25%)

1/48 (2.08%)

Gastrointestinal disorders

Dry Mouth¹,^†

# participants affected / at risk

1/49 (2.04%)

2/49 (4.08%)

4/49 (8.16%)

4/45 (8.89%)

3/48 (6.25%)

1/48 (2.08%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA

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:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.

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
No text entered.

Results Point of Contact

Name/Title:	Colin Reisner, MD, FCCP, FAAAAI
Organization:	Pearl Therapeutics, Inc
Phone	650-305-2600
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4164&filename=PT001002-00_Protocol_Redacted_23JAN2018.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Joseph Covino

975-975-0325

jcovino@pearltherapeutics.com

Contact Backup

Angela Castagna

973-975-0329

acastagna@pearltherapeutics.com

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics, Inc.

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Pearl Investigative Site

Pearl Investigative Site

Pearl Investigative Site

Pearl Investigative Site

Pearl Investigative Site

Pearl Investigative Site

Pearl Investigative Site

Pearl Investigative Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4164&filename=PT001002-00_Protocol_Redacted_23JAN2018.pdf

Trial Results Summaries