Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00690482)

NCT ID: NCT00690482

Last Updated: 2014-01-15

Results Overview

Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 118 participants
• Primary outcome timeframe: Baseline and Week 4
• Results posted on: 2014-01-15

Participant Flow

118 patients were allocated to treatment and 111 completed the study. First patient entered the study on 26 May 2008 and the last patient finished the study on 17 December 2008.

Participant milestones

Measure	AZD1981 AZD1981 Oral tablet, twice daily	Placebo Placebo Oral tablet, twice daily
Overall Study STARTED	61	57
Overall Study COMPLETED	57	54
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	AZD1981 AZD1981 Oral tablet, twice daily	Placebo Placebo Oral tablet, twice daily
Overall Study Adverse Event	2	1
Overall Study Incorrect enrolment	0	1
Overall Study Study-specific discontinuation criteria	1	0
Overall Study Intake of prohibited medicine	1	0
Overall Study withdrew consent at rand.day	0	1

Baseline Characteristics

Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Measure	AZD1981 n=61 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily	Total n=117 Participants Total of all reporting groups
Age, Continuous	64.1 Years n=5 Participants	62.4 Years n=7 Participants	62.4 Years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)

Outcome measures

Measure	AZD1981 n=60 Participants AZD1981 Oral tablet, twice daily	Placebo n=55 Participants Placebo Oral tablet, twice daily
FEV1	0.007 L Full Range -0.810 • Interval -0.81 to 0.74	0.011 L Full Range -0.550 • Interval -0.55 to 0.55

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).

Outcome measures

Measure	AZD1981 n=59 Participants AZD1981 Oral tablet, twice daily	Placebo n=55 Participants Placebo Oral tablet, twice daily
Clinical COPD Questionnaire	-0.299 Scores on a scale Full Range -2.00 • Interval -2.0 to 1.3	-0.340 Scores on a scale Full Range -2.20 • Interval -2.2 to 1.3

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)

Outcome measures

Measure	AZD1981 n=60 Participants AZD1981 Oral tablet, twice daily	Placebo n=55 Participants Placebo Oral tablet, twice daily
Forced Vital Capacity	-0.047 L Full Range -1.74 • Interval -1.74 to 0.84	-0.102 L Full Range -1.09 • Interval -1.09 to 0.87

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)

Outcome measures

Measure	AZD1981 n=60 Participants AZD1981 Oral tablet, twice daily	Placebo n=55 Participants Placebo Oral tablet, twice daily
Slow Vital Capacity	-0.001 L Full Range -1.03 • Interval -1.03 to 2.3	-0.009 L Full Range -1.60 • Interval -1.6 to 0.91

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)

Outcome measures

Measure	AZD1981 n=60 Participants AZD1981 Oral tablet, twice daily	Placebo n=54 Participants Placebo Oral tablet, twice daily
Inspiratory Capacity	-0.007 L Full Range -0.960 • Interval -0.96 to 1.08	-0.110 L Full Range -1.39 • Interval -1.39 to 1.59

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)

Outcome measures

Measure	AZD1981 n=60 Participants AZD1981 Oral tablet, twice daily	Placebo n=54 Participants Placebo Oral tablet, twice daily
FEF25%-75%	-0.042 L/s Full Range -0.900 • Interval -0.9 to 0.44	0.060 L/s Full Range -0.640 • Interval -0.64 to 2.48

SECONDARY outcome

Timeframe: Baseline and 4-week treatment period average

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).

Outcome measures

Measure	AZD1981 n=61 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily
COPD Symptom Sleep Score	-0.147 Scores on a scale Full Range -1.55 • Interval -1.55 to 1.0	-0.047 Scores on a scale Full Range -1.75 • Interval -1.75 to 1.8

SECONDARY outcome

Timeframe: Baseline and 4-week treatment period average

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).

Outcome measures

Measure	AZD1981 n=61 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily
COPD Symptom Breathing Score	-0.280 Scores on a scale Full Range -2.07 • Interval -2.07 to 0.486	-0.137 Scores on a scale Full Range -1.41 • Interval -1.41 to 1.52

SECONDARY outcome

Timeframe: Baseline and 4-week treatment period average

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).

Outcome measures

Measure	AZD1981 n=61 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily
COPD Symptom Cough Score	-0.202 Scores on a scale Full Range -2.09 • Interval -2.09 to 1.22	-0.124 Scores on a scale Full Range -1.79 • Interval -1.79 to 1.01

SECONDARY outcome

Timeframe: Baseline and 4-week treatment period average

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).

Outcome measures

Measure	AZD1981 n=61 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily
COPD Symptom Sputum Score	-0.300 Scores on a scale Full Range -1.50 • Interval -1.5 to 0.844	-0.290 Scores on a scale Full Range -1.58 • Interval -1.58 to 0.796

SECONDARY outcome

Timeframe: Baseline and 4-week treatment period average

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).

Outcome measures

Measure	AZD1981 n=61 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily
PEF (Peak Expiratory Flow) Morning	2.86 L/min Full Range -45.0 • Interval -45.0 to 113.0	4.54 L/min Full Range -37.2 • Interval -37.2 to 77.9

SECONDARY outcome

Timeframe: Baseline and 4-week treatment period average

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).

Outcome measures

Measure	AZD1981 n=60 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily
PEF (Peak Expiratory Flow) Evening	-1.61 L/min Full Range -66.5 • Interval -66.5 to 115.0	5.73 L/min Full Range -35.1 • Interval -35.1 to 61.8

SECONDARY outcome

Timeframe: Baseline and 4-week treatment period average

Population: The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.

Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).

Outcome measures

Measure	AZD1981 n=59 Participants AZD1981 Oral tablet, twice daily	Placebo n=55 Participants Placebo Oral tablet, twice daily
Total Use of Reliever	-0.330 Number of inhalations per day Full Range -7.64 • Interval -7.64 to 3.81	-0.139 Number of inhalations per day Full Range -3.69 • Interval -3.69 to 9.9

SECONDARY outcome

Timeframe: Up to 4 Weeks

Population: The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.

The number of participants that experienced at least one adverse event.

Outcome measures

Measure	AZD1981 n=61 Participants AZD1981 Oral tablet, twice daily	Placebo n=56 Participants Placebo Oral tablet, twice daily
Adverse Event	20 Participants	18 Participants

Adverse Events

AZD1981

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	AZD1981 n=61 participants at risk AZD1981 Oral tablet, twice daily	Placebo n=56 participants at risk Placebo Oral tablet, twice daily
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/61	1.8% 1/56

Other adverse events

Measure	AZD1981 n=61 participants at risk AZD1981 Oral tablet, twice daily	Placebo n=56 participants at risk Placebo Oral tablet, twice daily
Infections and infestations NASOPHARYNGITIS	9.8% 6/61	5.4% 3/56
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	6.6% 4/61	5.4% 3/56

Additional Information

Alison Holt

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60