Moderate to Severe COPD
Conditions
Keywords
COPD
Brief summary
The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
Interventions
DRUGAZD1981
Oral tablet, twice daily
DRUGPlacebo
Placebo Oral tablet, twice daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3) * Clinical diagnosis of COPD
Exclusion criteria
* Other clinically relevant disease or disorders * Exacerbation of COPD within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | Baseline and Week 4 | Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing) |
| Clinical COPD Questionnaire | Baseline and Week 4 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Capacity | Baseline and Week 4 | Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing) |
| FEF25%-75% | Baseline and Week 4 | 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) |
| COPD Symptom Sleep Score | Baseline and 4-week treatment period average | 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). |
| COPD Symptom Breathing Score | Baseline and 4-week treatment period average | 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). |
| COPD Symptom Cough Score | Baseline and 4-week treatment period average | 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). |
| Forced Vital Capacity | Baseline and Week 4 | Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing) |
| PEF (Peak Expiratory Flow) Morning | Baseline and 4-week treatment period average | Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient). |
| PEF (Peak Expiratory Flow) Evening | Baseline and 4-week treatment period average | Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient). |
| Total Use of Reliever | Baseline and 4-week treatment period average | Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient). |
| Adverse Event | Up to 4 Weeks | The number of participants that experienced at least one adverse event. |
| COPD Symptom Sputum Score | Baseline and 4-week treatment period average | 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). |
| Slow Vital Capacity | Baseline and Week 4 | Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing) |
Countries
Bulgaria, Denmark, Poland, Slovakia, Sweden
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| AZD1981 AZD1981 Oral tablet, twice daily | 61 |
| Placebo Placebo Oral tablet, twice daily | 56 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Incorrect enrolment | 0 | 1 |
| Overall Study | Intake of prohibited medicine | 1 | 0 |
| Overall Study | Study-specific discontinuation criteria | 1 | 0 |
| Overall Study | withdrew consent at rand.day | 0 | 1 |
Baseline characteristics
| Characteristic | AZD1981 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 64.1 Years | 62.4 Years | 62.4 Years |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 49 Participants | 48 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 61 | 6 / 56 |
| serious Total, serious adverse events | 0 / 61 | 1 / 56 |
Outcome results
Primary
Clinical COPD Questionnaire
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | Clinical COPD Questionnaire | -0.299 Scores on a scale | Full Range -2 |
| Placebo | Clinical COPD Questionnaire | -0.340 Scores on a scale | Full Range -2.2 |
Primary
FEV1
Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | FEV1 | 0.007 L | Full Range -0.81 |
| Placebo | FEV1 | 0.011 L | Full Range -0.55 |
Secondary
Adverse Event
The number of participants that experienced at least one adverse event.
Time frame: Up to 4 Weeks
Population: The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD1981 | Adverse Event | 20 Participants |
| Placebo | Adverse Event | 18 Participants |
Secondary
COPD Symptom Breathing Score
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | COPD Symptom Breathing Score | -0.280 Scores on a scale | Full Range -2.07 |
| Placebo | COPD Symptom Breathing Score | -0.137 Scores on a scale | Full Range -1.41 |
Secondary
COPD Symptom Cough Score
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | COPD Symptom Cough Score | -0.202 Scores on a scale | Full Range -2.09 |
| Placebo | COPD Symptom Cough Score | -0.124 Scores on a scale | Full Range -1.79 |
Secondary
COPD Symptom Sleep Score
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | COPD Symptom Sleep Score | -0.147 Scores on a scale | Full Range -1.55 |
| Placebo | COPD Symptom Sleep Score | -0.047 Scores on a scale | Full Range -1.75 |
Secondary
COPD Symptom Sputum Score
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | COPD Symptom Sputum Score | -0.300 Scores on a scale | Full Range -1.5 |
| Placebo | COPD Symptom Sputum Score | -0.290 Scores on a scale | Full Range -1.58 |
Secondary
FEF25%-75%
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | FEF25%-75% | -0.042 L/s | Full Range -0.9 |
| Placebo | FEF25%-75% | 0.060 L/s | Full Range -0.64 |
Secondary
Forced Vital Capacity
Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | Forced Vital Capacity | -0.047 L | Full Range -1.74 |
| Placebo | Forced Vital Capacity | -0.102 L | Full Range -1.09 |
Secondary
Inspiratory Capacity
Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | Inspiratory Capacity | -0.007 L | Full Range -0.96 |
| Placebo | Inspiratory Capacity | -0.110 L | Full Range -1.39 |
Secondary
PEF (Peak Expiratory Flow) Evening
Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | PEF (Peak Expiratory Flow) Evening | -1.61 L/min | Full Range -66.5 |
| Placebo | PEF (Peak Expiratory Flow) Evening | 5.73 L/min | Full Range -35.1 |
Secondary
PEF (Peak Expiratory Flow) Morning
Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | PEF (Peak Expiratory Flow) Morning | 2.86 L/min | Full Range -45 |
| Placebo | PEF (Peak Expiratory Flow) Morning | 4.54 L/min | Full Range -37.2 |
Secondary
Slow Vital Capacity
Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | Slow Vital Capacity | -0.001 L | Full Range -1.03 |
| Placebo | Slow Vital Capacity | -0.009 L | Full Range -1.6 |
Secondary
Total Use of Reliever
Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1981 | Total Use of Reliever | -0.330 Number of inhalations per day | Full Range -7.64 |
| Placebo | Total Use of Reliever | -0.139 Number of inhalations per day | Full Range -3.69 |