A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients while on Maintenance Therapy

Study identifier:D2550C00005

ClinicalTrials.gov identifier:NCT02238483

EudraCT identifier:2014-001053-16

CTIS identifier:N/A

Study Complete

Official Title

A 12-week Phase IIa, Double-blind, Placebo-controlled, Randomized Study to Investigate the Efficacy and Safety of AZD7624 in COPD Patients with a History of Frequent Acute Exacerbations while on Maintenance Therapy

Medical condition

Chronic Obstructive Pulmonary Disease COPD

Phase

Phase 2

Healthy volunteers

Study drug

AZD7624 1.0 mg, Placebo

Sex

All

Actual Enrollment

215

Study type

Interventional

Age

40 Years - 85 Years

Date

Study Start Date: 28 Oct 2014

Primary Completion Date: 04 Apr 2016

Study Completion Date: 04 Apr 2016

Study design

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

Verification:

Verified 01 Apr 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Provision of signed and dated written informed consent prior to any study specific procedures.
- Male and females aged 40-85 years. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential. Males must be surgically sterile or agree to use an acceptable method of contraception for the duration of the study and for 3 months after the last dose of investigational product to prevent pregnancy in a partner.
- A weight of ≥50 kg.
- Diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
- COPD maintenance treatment with at least ICS/LABA for at least 2 months prior to enrolment to be continued unchanged during the study.
- A post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator FEV1 ≤70% of the predicted normal value. Documented history of 2 or more moderate to severe COPD exacerbations within 12 months of randomisation, but not within the last 6 weeks before randomisation.
- Current or ex-smokers with a smoking history of at least 10 pack-years.

Exclusion Criteria

- Involvement in the planning and conduct of the study.
- Previous randomisation in the present study.
- Participation in another clinical study with any investigational medicinal product within 3 months of randomisation. Previously intake of any p38 inhibitor.
- Participation in, or scheduled for an intensive COPD rehabilitation programme at any time during the study.
- Planned in-patient surgery or hospitalisation during the study.
- Significant disease or disorder other than COPD which, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient’s ability to participate in the study. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines (GINA 2013) or other accepted guidelines.
- A clinically relevant abnormal findings in clinical chemistry, haematology and urinalysis.
- Plasma myoglobin and CK above the upper reference range of the analysing laboratory at randomization.
- A clinically relevant abnormal findings in physical examination, pulse or blood pressure.
- A positive result on screening for serum hepatitis B hepatitis C and Human Immunodeficiency Virus (HIV).
- History or family history of muscle diseases. Abnormal vital signs, defined as Systolic Blood Pressure (SBP) above 140 mmHg if <60 years of age and above 150 mmHg if ≥60 years of age; Diastolic Blood Pressure (DBP) above 90 mmHg; Pulse <50 or >100 bpm.
- Prolonged QTcF >450 ms or family history of long QT syndrome or sudden death at young age. PR(PQ) interval of clinical significance, PR(PQ) > 250 ms.
- Intermittent AV block of 2nd and 3rd degree or AV dissociation.
- Patients with a QRS duration >120 ms.
- Patients with persistent, and/or recurrent symptomatic tachyarrhythmias, as well as patients with an implantable cardioverter-defibrillator (ICD) or a permanent pacemaker.
- Patients with recent Cardiovascular (CV) events or unstable CV disease or a myocardial infarction or stroke within 6 months of screening. History of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624.
- Any exacerbation or respiratory infection within 6 weeks of randomization.
- Plasma donation within one month of Visit 1, or any blood donation/blood loss >500 mL during the 3 months prior to Visit 1.
- History of, or current alcohol or drug abuse.
- Treatment with any GCS (apart from prescribed steroids at run-in) within 6 weeks of Visit 3 regardless of indication.
- Treatment with strong CYP3A inhibitors within 4 weeks prior to randomisation.

Location

Research Site

HEERLEN, Netherlands, 6419 PC

Location

Research Site

Nijmegen, Netherlands, 6525 GA

Location

Research Site

ASSEN, Netherlands, 9401 RK

Location

Research Site

Zutphen, Netherlands, 7207 AE

Location

Research Site

Gaffney, SC, United States, 29340

Location

Research Site

Erie, PA, United States, 16508

Location

Research Site

Saint Louis, MO, United States, 63141

Location

Research Site

Kingwood, TX, United States, 77339

Arms	Assigned Interventions
Experimental: AZD7624 Active treatment	Drug: AZD7624 1.0 mg Inhaled AZD7624 solution, 11 mg/mL
Placebo Comparator: Placebo Placebo Comparator	Drug: Placebo Inhaled placebo solution

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a multi-centre study conducted at 39 study centres in 6 countries: Argentina (37.7% of the patients); United States (34.4%) Peru (9%) Chile (6.6%) The Netherlands (6.1%) and South Africa (6.1%) A seasonal recruitment strategy was undertaken where patients were recruited in the fall and winter months of the geographic locality.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
327 patients signed informed consent, of which 213 patients were randomised. The majority of the 114 not randomised were screening failures

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Participant Flow: Overall Study

	AZD7624	Placebo
STARTED	108	105
COMPLETED	93	91
NOT COMPLETED	15	14
Withdrawal by Subject	2	7
Lost to Follow-up	1	1
Protocol Violation	1	2
Death	1	0
Adverse Event	7	3
Withdrawn due to physician decision	1	0
Completion status not recorded	1	1
Illness in family member	1	0

Baseline Characteristics

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

One patient was excluded from the Full Analysis Set due to lack of source data and GCP compliance issues.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Baseline Measures

	AZD7624	Placebo	Total
Number of Participants [units: Participants]	107	105	212
Age Continuous [units: Years] Mean ± Standard Deviation	65.4 ± 8.73	64.2 ± 8.67	64.8 ± 8.70
Age Categorical [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	49	54	103
>=65 years	58	51	109
Gender, Male/Female [units: Participants]
Female	40	36	76
Male	67	69	136
Race/Ethnicity, Customized [units: Participants]
American Indian or Alaska Native	3	4	7
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	7	2	9
White	85	88	173
Other	12	11	23
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	66	65	131
Not Hispanic or Latino	41	40	81
Unknown or Not Reported	0	0	0

Outcome Measures

1. Primary Outcome Measure: Time to first moderate to severe COPD exacerbation or early drop-out related to worsening of COPD symptoms [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Primary
Measure Name	Time to first moderate to severe COPD exacerbation or early drop-out related to worsening of COPD symptoms
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Time to first moderate to severe COPD exacerbation or early drop-out related to worsening of COPD symptoms [units: days] Median (Full Range)	N/A (5 to NA) ^[1]	118.0 (4 to NA) ^[1]

Statistical Analysis 1 for Time to first moderate to severe COPD exacerbation or early drop-out related to worsening of COPD symptoms

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.2371
Hazard Ratio (HR)^[5]	1.39
95% Confidence Interval	( 0.81 to 2.40 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	H0: Hazard Ratio (AZD7624/placebo) equals 1 vs. H1: Hazard Ratio does not equal 1.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.

2. Secondary Outcome Measure: Annual event rate of moderate and severe COPD exacerbations and early drop-outs related to worsening of COPD symptoms (i.e. composite endpoint, ExDo) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Annual event rate of moderate and severe COPD exacerbations and early drop-outs related to worsening of COPD symptoms (i.e. composite endpoint, ExDo)
Measure Description	For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Event Rate = No. of Events*365.25 / (Follow-up date – Date of randomization + 1).
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Annual event rate of moderate and severe COPD exacerbations and early drop-outs related to worsening of COPD symptoms (i.e. composite endpoint, ExDo) [units: Events / year] Least Squares Mean (Standard Error)	2.16 (0.80)	1.62 (0.63)

Statistical Analysis 1 for Annual event rate of moderate and severe COPD exacerbations and early drop-outs related to worsening of COPD symptoms (i.e. composite endpoint, ExDo)

Groups^[1]	All groups
Method^[3]	Other [regression, negative binomial]
P-Value^[4]	0.249
Other^[5]	1.33
Standard Error of the mean	± 0.33
95% Confidence Interval	( 0.82 to 2.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.

3. Secondary Outcome Measure: Time to first event of moderate or severe COPD exacerbations or early drop-out (including drop-outs due to any cause) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Time to first event of moderate or severe COPD exacerbations or early drop-out (including drop-outs due to any cause)
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Time to first event of moderate or severe COPD exacerbations or early drop-out (including drop-outs due to any cause) [units: days] Median (Full Range)	N/A (5 to NA) ^[1]	118.0 (4 to NA) ^[1]

Statistical Analysis 1 for Time to first event of moderate or severe COPD exacerbations or early drop-out (including drop-outs due to any cause)

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.1261
Hazard Ratio (HR)^[5]	1.49
95% Confidence Interval	( 0.89 to 2.50 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.

4. Secondary Outcome Measure: Annual event rate of moderate and severe COPD exacerbations and early drop-outs (including drop-outs due to any cause) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Annual event rate of moderate and severe COPD exacerbations and early drop-outs (including drop-outs due to any cause)
Measure Description	For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Event Rate = No. of Events*365.25 / (Follow-up date – Date of randomization + 1).
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Annual event rate of moderate and severe COPD exacerbations and early drop-outs (including drop-outs due to any cause) [units: Events / year] Least Squares Mean (Standard Error)	2.17 (0.80)	1.55 (0.60)

Statistical Analysis 1 for Annual event rate of moderate and severe COPD exacerbations and early drop-outs (including drop-outs due to any cause)

Groups^[1]	All groups
Method^[3]	Other [regression, negative binomial]
P-Value^[4]	0.157
Other^[5]	1.40
Standard Error of the mean	± 0.33
95% Confidence Interval	( 0.88 to 2.21 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Time to first moderate or severe exacerbation [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Time to first moderate or severe exacerbation
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Time to first moderate or severe exacerbation [units: days] Median (Full Range)	N/A (5 to NA) ^[1]	N/A (4 to NA) ^[1]

Statistical Analysis 1 for Time to first moderate or severe exacerbation

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.1529
Hazard Ratio (HR)^[5]	1.53
95% Confidence Interval	( 0.85 to 2.76 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

6. Secondary Outcome Measure: Annual exacerbation rate of moderate and severe exacerbations [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Annual exacerbation rate of moderate and severe exacerbations
Measure Description	For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date – Date of randomization + 1).
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Annual exacerbation rate of moderate and severe exacerbations [units: Exacerbations / year] Least Squares Mean (Standard Error)	2.12 (0.78)	1.42 (0.56)

Statistical Analysis 1 for Annual exacerbation rate of moderate and severe exacerbations

Groups^[1]	All groups
Method^[3]	Other [regression, negative binomial]
P-Value^[4]	0.129
Other^[5]	1.50
Standard Error of the mean	± 0.40
95% Confidence Interval	( 0.89 to 2.52 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

7. Secondary Outcome Measure: Time to first moderate or severe exacerbation (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Time to first moderate or severe exacerbation (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled)
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Time to first moderate or severe exacerbation (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled) [units: days] Median (Full Range)	N/A (6 to NA) ^[1]	N/A (4 to NA) ^[1]

Statistical Analysis 1 for Time to first moderate or severe exacerbation (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled)

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.8543
Hazard Ratio (HR)^[5]	0.93
95% Confidence Interval	( 0.43 to 2.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.

8. Secondary Outcome Measure: Annual exacerbation rate of moderate and severe exacerbations (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Annual exacerbation rate of moderate and severe exacerbations (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled)
Measure Description	For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date – Date of randomization + 1).
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Annual exacerbation rate of moderate and severe exacerbations (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled) [units: Exacerbations / year] Least Squares Mean (Standard Error)	1.23 (0.39)	1.09 (0.37)

Statistical Analysis 1 for Annual exacerbation rate of moderate and severe exacerbations (where worsening of COPD symptoms is defined as Anthonisens criteria fulfilled)

Groups^[1]	All groups
Method^[3]	Other [regression, negative binomial]
P-Value^[4]	0.751
Other^[5]	1.12
Standard Error of the mean	± 0.41
95% Confidence Interval	( 0.55 to 2.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

9. Secondary Outcome Measure: Time to first symptom defined exacerbation (as defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] daily diary) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Time to first symptom defined exacerbation (as defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] daily diary)
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Time to first symptom defined exacerbation (as defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] daily diary) [units: days] Median (Full Range)	N/A (3 to NA) ^[1]	N/A (2 to NA) ^[1]

Statistical Analysis 1 for Time to first symptom defined exacerbation (as defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] daily diary)

Groups^[1]	All groups
Method^[3]	Regression, Cox
P-Value^[4]	0.5381
Hazard Ratio (HR)^[5]	0.86
95% Confidence Interval	( 0.54 to 1.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.

10. Secondary Outcome Measure: Annual exacerbation rate of symptom defined exacerbations (as defined by the EXACT daily diary) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Annual exacerbation rate of symptom defined exacerbations (as defined by the EXACT daily diary)
Measure Description	For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date – Date of randomization + 1).
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Annual exacerbation rate of symptom defined exacerbations (as defined by the EXACT daily diary) [units: Exacerbations / year] Least Squares Mean (Standard Error)	1.96 (0.54)	2.33 (0.64)

Statistical Analysis 1 for Annual exacerbation rate of symptom defined exacerbations (as defined by the EXACT daily diary)

Groups^[1]	All groups
Method^[3]	Other [regression, negative binomial]
P-Value^[4]	0.440
Other^[5]	0.84
Standard Error of the mean	± 0.19
95% Confidence Interval	( 0.55 to 1.30 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

11. Secondary Outcome Measure: Symptoms of COPD (using the EXACT for Respiratory Symptoms [E-RS] Total Score, a subset of items from the EXACT diary) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Symptoms of COPD (using the EXACT for Respiratory Symptoms [E-RS] Total Score, a subset of items from the EXACT diary)
Measure Description	The EXACT for Respiratory Symptoms (E-RS) scale is a derivative instrument comprising a subset of 11 of the EXACT items to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	106	105
Symptoms of COPD (using the EXACT for Respiratory Symptoms [E-RS] Total Score, a subset of items from the EXACT diary) [units: scores on a scale] Least Squares Mean (Standard Error)	-0.21 (0.88)	0.17 (0.91)

Statistical Analysis 1 for Symptoms of COPD (using the EXACT for Respiratory Symptoms [E-RS] Total Score, a subset of items from the EXACT diary)

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.5474
Mean Difference (Net)^[5]	-0.37
95% Confidence Interval	( -1.60 to 0.85 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	LSMean difference for overall treatment effect. Negative values for a difference show AZD7624 to have a favourable outcome compared to Placebo

12. Secondary Outcome Measure: Health related quality of life (as assessed by St Georges Respiratory Questionnaire for COPD patients [SGRQ-C]) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Health related quality of life (as assessed by St Georges Respiratory Questionnaire for COPD patients [SGRQ-C])
Measure Description	The SGRQ-C is a modified version of the St. George’s Respiratory Questionnaire, which has been developed to measure the impact of respiratory disease on health status. The SGRQ-C includes 14 questions in 3 domains: symptoms; activity; and impacts. Scores range from 0 to 100 with higher scores indicating benefit. Change in total score from pre study-treatment baseline to Week 12 end of treatment visit are reported.
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	107	105
Health related quality of life (as assessed by St Georges Respiratory Questionnaire for COPD patients [SGRQ-C]) [units: scores on a scale] Mean (Standard Deviation)	-4.03 (19.574)	-5.11 (17.809)

Statistical Analysis 1 for Health related quality of life (as assessed by St Georges Respiratory Questionnaire for COPD patients [SGRQ-C])

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.6352
Mean Difference (Net)^[5]	0.83
95% Confidence Interval	( -2.62 to 4.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo

13. Secondary Outcome Measure: Dyspnea (Transitional Dyspnea Index (TDI) score) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Dyspnea (Transitional Dyspnea Index (TDI) score)
Measure Description	The Baseline/Transitional Dyspnea Index (BDI/TDI) provides a multidimensional measure of dyspnea in relation to activities of daily living. The BDI provides a measure of dyspnoea at a single state, the baseline, and the TDI evaluates changes in dyspnoea from the baseline state. The instrument consists of three components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these three components are rated in five grades from 0 (severe) to 4 (unimpaired), and are summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea are rated for each component by seven grades from -3 (major deterioration) to +3 (major improvement), and are added to form a total TDI score from -9 to +9. Positive scores indicate an improvement, and a change from the BDI or a difference between treatments of 1 point has been estimated to constitute the minimum clinically important difference.
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. Only patients with post-baseline TDI scores were included in the analysis.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	102	100
Dyspnea (Transitional Dyspnea Index (TDI) score) [units: score on a scale] Least Squares Mean (Standard Error)	0.41 (0.15)	0.54 (0.16)

Statistical Analysis 1 for Dyspnea (Transitional Dyspnea Index (TDI) score)

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.2694
Mean Difference (Net)^[5]	-0.12
95% Confidence Interval	( -0.34 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo

14. Secondary Outcome Measure: Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Expiratory Volume in 1 second (FEV1)
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	107	105
Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Expiratory Volume in 1 second (FEV1) [units: Litres] Mean (Standard Deviation)	-0.003 (0.2555)	-0.028 (0.2317)

Statistical Analysis 1 for Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Expiratory Volume in 1 second (FEV1)

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.5144
Mean Difference (Net)^[5]	0.02
95% Confidence Interval	( -0.03 to 0.07 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo

15. Secondary Outcome Measure: Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Vital Capacity (FVC) [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Vital Capacity (FVC)
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	107	105
Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Vital Capacity (FVC) [units: Litres] Mean (Standard Deviation)	-0.045 (0.4017)	-0.018 (0.3890)

Statistical Analysis 1 for Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough Forced Vital Capacity (FVC)

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.5416
Mean Difference (Net)^[5]	-0.02
95% Confidence Interval	( -0.10 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo

16. Secondary Outcome Measure: Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough FEV1/FVC ratio [ Time Frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days) ]

Measure Type	Secondary
Measure Name	Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough FEV1/FVC ratio
Measure Description
Time Frame	Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
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.
Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Measured Values

	AZD7624	Placebo
Number of Participants Analyzed [units:participants]	107	105
Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough FEV1/FVC ratio [units: L/L] Mean (Standard Deviation)	0.0077 (0.05269)	-0.0072 (0.05255)

Statistical Analysis 1 for Pulmonary function measured as changes from baseline (post-bronchodilator at visit 3) in trough FEV1/FVC ratio

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.1965
Mean Difference (Net)^[5]	0.01
95% Confidence Interval	( 0.00 to 0.02 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo

Serious Adverse Events

Time Frame	Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
Additional Description	No text entered.

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Serious Adverse Events

AZD7624

Placebo

Total, serious adverse events

# participants affected / at risk

11/108 (10.19%)

11/105 (10.48%)

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹

# participants affected / at risk

7/108 (6.48%)

6/105 (5.71%)

Cardiac disorders

Angina unstable¹

# participants affected / at risk

0/108 (0.00%)

1/105 (0.95%)

Cardiac disorders

Cardiac arrest¹

# participants affected / at risk

1/108 (0.93%)

0/105 (0.00%)

Cardiac disorders

Coronary artery occlusion¹

# participants affected / at risk

1/108 (0.93%)

0/105 (0.00%)

Hepatobiliary disorders

Biliary colic¹

# participants affected / at risk

0/108 (0.00%)

1/105 (0.95%)

Hepatobiliary disorders

Cholelithiasis¹

# participants affected / at risk

0/108 (0.00%)

1/105 (0.95%)

Musculoskeletal and connective tissue disorders

Back pain¹

# participants affected / at risk

1/108 (0.93%)

0/105 (0.00%)

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain¹

# participants affected / at risk

0/108 (0.00%)

1/105 (0.95%)

Gastrointestinal disorders

Nausea¹

# participants affected / at risk

1/108 (0.93%)

0/105 (0.00%)

Infections and infestations

Urosepsis¹

# participants affected / at risk

1/108 (0.93%)

0/105 (0.00%)

Injury, poisoning and procedural complications

Subdural haematoma¹

# participants affected / at risk

0/108 (0.00%)

1/105 (0.95%)

Nervous system disorders

Syncope¹

# participants affected / at risk

0/108 (0.00%)

1/105 (0.95%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 18.0

Other Adverse Events

Time Frame	Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
AZD7624	Active treatment 2 x 0.5mg inhalation qd
Placebo	Matching placebo comparator

Other Adverse Events

AZD7624

Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

71/108 (65.74%)

48/105 (45.71%)

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹

# participants affected / at risk

31/108 (28.70%)

23/105 (21.90%)

Respiratory, thoracic and mediastinal disorders

Cough¹

# participants affected / at risk

8/108 (7.41%)

2/105 (1.90%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹

# participants affected / at risk

8/108 (7.41%)

4/105 (3.81%)

Nervous system disorders

Dysgeusia¹

# participants affected / at risk

5/108 (4.63%)

1/105 (0.95%)

Infections and infestations

Influenza¹

# participants affected / at risk

5/108 (4.63%)

3/105 (2.86%)

Musculoskeletal and connective tissue disorders

Back pain¹

# participants affected / at risk

4/108 (3.70%)

1/105 (0.95%)

Infections and infestations

Bronchitis¹

# participants affected / at risk

4/108 (3.70%)

2/105 (1.90%)

Infections and infestations

Nasopharyngitis¹

# participants affected / at risk

4/108 (3.70%)

4/105 (3.81%)

General disorders

Fatigue¹

# participants affected / at risk

3/108 (2.78%)

0/105 (0.00%)

Vascular disorders

Hypertension¹

# participants affected / at risk

3/108 (2.78%)

2/105 (1.90%)

Respiratory, thoracic and mediastinal disorders

Productive cough¹

# participants affected / at risk

3/108 (2.78%)

0/105 (0.00%)

General disorders

Asthenia¹

# participants affected / at risk

2/108 (1.85%)

4/105 (3.81%)

Infections and infestations

Sinusitis¹

# participants affected / at risk

1/108 (0.93%)

3/105 (2.86%)

General disorders

Oedema peripheral¹

# participants affected / at risk

0/108 (0.00%)

3/105 (2.86%)

Musculoskeletal and connective tissue disorders

Pain in extremity¹

# participants affected / at risk

0/108 (0.00%)

3/105 (2.86%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 18.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.

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:	Ziad Taib
Organization:	AstraZeneca
Phone	+46 708 46 73 56
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Clinical Study Information

+1 800-236-9933

Investigators

Principal Investigator

Naimish Patel

AstraZeneca R&D Boston

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Trial Results Summaries