Trial Outcomes & Findings for Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00629239)
NCT ID: NCT00629239
Last Updated: 2010-12-06
Results Overview
Number of patients who had an Adverse Event
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
At all study visits
Results posted on
2010-12-06
Participant Flow
One participant was excluded in the analysis sets since this participat is non-informative both in terms of efficacy and safety, and was immediately withdrawn for non-treatment related reasons. AZD4818 Turbuhaler group will include 33 patients in all other sections
Participant milestones
| Measure |
AZD4818
AZD4818 Turbuhaler
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
AZD4818
AZD4818 Turbuhaler
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65 years
n=5 Participants
|
66 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At all study visitsNumber of patients who had an Adverse Event
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Number of Patients Experiencing Adverse Events
|
22 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Before treatment and after 1, 2, 3 and 4 weeks of treatmentChange in (FEV1) from baseline to end of treatment
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Forced Expiratory Volume 1 (FEV1)
|
-0.083 L
Full Range -0.5 • Interval -0.5 to 0.62
|
-0.149 L
Full Range -1.05 • Interval -1.05 to 0.22
|
SECONDARY outcome
Timeframe: Before treatment and after 1, 2, 3 and 4 weeks of treatmentChange in FVC from baseline to end of treatment
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Forced Vital Capacity (FVC)
|
-0.044 L
Full Range -1.02 • Interval -1.02 to 0.95
|
-0.240 L
Full Range -1.54 • Interval -1.54 to 0.73
|
SECONDARY outcome
Timeframe: Before treatment and after 1, 2, 3 and 4 weeks of treatmentChange in VC from baseline to end of treatment
Outcome measures
| Measure |
AZD4818
n=32 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Vital Capacity (VC)
|
-0.022 L
Full Range -0.86 • Interval -0.86 to 1.92
|
-0.022 L
Full Range -1.25 • Interval -1.25 to 0.86
|
SECONDARY outcome
Timeframe: Before treatment and after 1, 2, 3 and 4 weeks of treatmentChange from IC baseline to end of treatment
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Inspiratory Capacity (IC)
|
-0.117 L
Full Range -1.02 • Interval -1.02 to 0.83
|
-0.038 L
Full Range -0.73 • Interval -0.73 to 1.04
|
SECONDARY outcome
Timeframe: Before treatment and after 1, 2, 3 and 4 weeks of treatmentChange in FEF from baseline to end of treatment
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Forced Expiratory Flow (FEF) 25%-75%
|
-0.027 L/s
Full Range -0.19 • Interval -0.19 to 0.18
|
0.006 L/s
Full Range -0.49 • Interval -0.49 to 0.51
|
SECONDARY outcome
Timeframe: Daily during run-in and treatmentChange from average during run-in to average during treatment
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Peak Expiratory Flow (PEF) Morning
|
-9.10 L/min
Full Range -62.8 • Interval -62.8 to 45.9
|
-4.47 L/min
Full Range -43.3 • Interval -43.3 to 32.9
|
SECONDARY outcome
Timeframe: Daily during run-in and treatmentChange in PEF from average during run-in to average during treatment
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Peak Expiratory Flow (PEF) Evening
|
-12.4 L/min
Interval -42.9 to 35.9
|
-1.90 L/min
Interval -33.0 to 34.2
|
SECONDARY outcome
Timeframe: Before treatment and after 1, 2, 3 and 4 weeks of treatmentChange from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
|
0.250 Score on a scale
Full Range -1.08 • Interval -1.08 to 2.0
|
0.044 Score on a scale
Full Range -1.58 • Interval -1.58 to 3.08
|
SECONDARY outcome
Timeframe: Daily during run-in and treatmentChange from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
|
0.159 Scores on a scale
Full Range -0.446 • Interval -0.446 to 1.23
|
-0.007 Scores on a scale
Full Range -1.18 • Interval -1.18 to 1.4
|
SECONDARY outcome
Timeframe: Daily during run-in and treatmentChange from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
|
0.170 Score on a scale
Full Range -0.823 • Interval -0.823 to 2.44
|
0.024 Score on a scale
Full Range -0.807 • Interval -0.807 to 0.847
|
SECONDARY outcome
Timeframe: Daily during run-in and treatmentChange from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
|
0.064 Scores on a scale
Full Range -0.431 • Interval -0.431 to 1.15
|
-0.103 Scores on a scale
Full Range -1.91 • Interval -1.91 to 0.867
|
SECONDARY outcome
Timeframe: Daily during run-in and treatmentChange from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
|
0.085 Scores on a scale
Interval -0.926 to 1.15
|
0.000 Scores on a scale
Interval -1.19 to 0.889
|
SECONDARY outcome
Timeframe: Before treatment and after 4 weeks of treatmentChange from baseline to end of treatment
Outcome measures
| Measure |
AZD4818
n=33 Participants
AZD4818 Turbuhaler
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
6-minute Walk Test
|
-8.67 meter
Full Range -163 • Interval -163.0 to 90.0
|
-6.67 meter
Full Range -125 • Interval -125.0 to 112.0
|
Adverse Events
AZD4818
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD4818
n=33 participants at risk
AZD4818 Turbuhaler
|
Placebo
n=32 participants at risk
Placebo
|
|---|---|---|
|
Vascular disorders
Deep Venous Thrombosis Left Lower Leg
|
3.0%
1/33
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
3.0%
1/33
|
0.00%
0/32
|
Other adverse events
| Measure |
AZD4818
n=33 participants at risk
AZD4818 Turbuhaler
|
Placebo
n=32 participants at risk
Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructuve pulmonary disease
|
27.3%
9/33
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
3/33
|
21.9%
7/32
|
|
Infections and infestations
nasopharyngitis
|
3.0%
1/33
|
25.0%
8/32
|
|
Nervous system disorders
Tremor
|
15.2%
5/33
|
0.00%
0/32
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
2/33
|
9.4%
3/32
|
|
Nervous system disorders
Headache
|
9.1%
3/33
|
3.1%
1/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees to collaborate with AZ in regard to the contents and formation of any publication or disclosure and to considerate the comments,views and opinions offered by AZ. Prior to any publication or disclosure the PI will provide AZ with preliminary data and drafts of proposed publication or disclosure and the proposed final manuscript. AZ will have a period of 30 days from receipt of the proposed final manuscript to review and may require submission for publication or disclosure be delayed
- Publication restrictions are in place
Restriction type: OTHER