Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo (inactive substance) in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.
Interventions
DRUGAZD1236
oral tablet, 75 mg, twice daily during 6 weeks
DRUGPlacebo
Dosing to match AZD1236
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD for 1 month * Men or postmenopausal women * Spirometry values indicating reduced lung function * Smoking history equivalent to using 20 cigarettes a day for 10 years
Exclusion criteria
* Any current respiratory tract disorders other than COPD * Requirement for regular oxygen therapy * Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | all study visits | Number of patients who had an Adverse Event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity (FVC) | Before treatment and after 1, 2, 4 and 6 weeks of treatment | Change in FVC from baseline to end of treatment |
| Vital Capacity (VC) | Before treatment and after 1, 2, 4 and 6 weeks of treatment | Change in VC from baseline to end of treatment |
| Inspiratory Capacity (IC) | Before treatment and after 1, 2, 4 and 6 weeks of treatment | Change in IC from baseline to end of treatment |
| Forced Expiratory Flow (FEF)25-75% | Before treatment and after 1, 2, 4 and 6 weeks of treatment | Change in FEF from baseline to end of treatment |
| Peak Expiratory Flow (PEF) Morning | Daily during run-in and treatment | Change in PEF from average during run-in to average during the last 4 w of treatment |
| Peak Expiratory Flow (PEF) Evening | Daily during run-in and treatment | Change in PEF from average during run-in to average during the last 4 w of treatment |
| Forced Expiratory Volume in 1 Second (FEV1) | Before treatment and after 1, 2, 4 and 6 weeks of treatment | Change in FEV1 from baseline to end of treatment |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Daily during run-in and treatment | Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Daily during run-in and treatment | Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Daily during run-in and treatment | Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings | Daily during run-in and treatment | Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) |
| 6-minute Walk Test | Before treatment and after 6 weeks of treatment | Change from baseline to end of treatment |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total | Before treatment and after 1, 2, 4 and 6 weeks of treatment | Change 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) |
Countries
Bulgaria, Finland, Germany, Hungary, Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZD1236 AZD1236 | 35 |
| Placebo Placebo | 39 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | AZD1236 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 61.7 Year | 61.7 Year | 61.7 Year |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 35 | 8 / 39 |
| serious Total, serious adverse events | 1 / 35 | 0 / 39 |
Outcome results
Primary
Incidence of Adverse Events
Number of patients who had an Adverse Event
Time frame: all study visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD1236 | Incidence of Adverse Events | 13 Participants |
| Placebo | Incidence of Adverse Events | 17 Participants |
Secondary
6-minute Walk Test
Change from baseline to end of treatment
Time frame: Before treatment and after 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | 6-minute Walk Test | 14.4 m | Full Range -117 |
| Placebo | 6-minute Walk Test | 9.68 m | Full Range -111 |
Secondary
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total
Change 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)
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total | 0.373 Score on scale | Full Range 0.27 |
| Placebo | Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total | -0.374 Score on scale | Full Range -4.8 |
Secondary
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | -0.173 Score on scale | Full Range -1.22 |
| Placebo | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | -0.390 Score on scale | Full Range -2.15 |
Secondary
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | -0.073 Scores on a Scale | Full Range -1.1 |
| Placebo | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | -0.212 Scores on a Scale | Full Range -1.89 |
Secondary
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | -0.200 Scores on a Scale | Full Range -1.36 |
| Placebo | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | -0.470 Scores on a Scale | Full Range -1.73 |
Secondary
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings
Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings | -0.128 Score on scale | Full Range -1.11 |
| Placebo | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings | -0.262 Score on scale | Full Range -2 |
Secondary
Forced Expiratory Flow (FEF)25-75%
Change in FEF from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Forced Expiratory Flow (FEF)25-75% | -0.073 L/s | Full Range -1.45 |
| Placebo | Forced Expiratory Flow (FEF)25-75% | 0.010 L/s | Full Range -0.28 |
Secondary
Forced Expiratory Volume in 1 Second (FEV1)
Change in FEV1 from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Forced Expiratory Volume in 1 Second (FEV1) | -0.006 L | Full Range -0.41 |
| Placebo | Forced Expiratory Volume in 1 Second (FEV1) | 0.003 L | Full Range -0.45 |
Secondary
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Forced Vital Capacity (FVC) | -0.048 L | Full Range -0.76 |
| Placebo | Forced Vital Capacity (FVC) | -0.028 L | Full Range -0.73 |
Secondary
Inspiratory Capacity (IC)
Change in IC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Inspiratory Capacity (IC) | -0.083 L | Full Range -0.73 |
| Placebo | Inspiratory Capacity (IC) | 0.053 L | Full Range -0.62 |
Secondary
Peak Expiratory Flow (PEF) Evening
Change in PEF from average during run-in to average during the last 4 w of treatment
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Peak Expiratory Flow (PEF) Evening | 7.48 L/min | Full Range -70.4 |
| Placebo | Peak Expiratory Flow (PEF) Evening | 6.69 L/min | Full Range -48.1 |
Secondary
Peak Expiratory Flow (PEF) Morning
Change in PEF from average during run-in to average during the last 4 w of treatment
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Peak Expiratory Flow (PEF) Morning | 1.45 L/min | Full Range -78.4 |
| Placebo | Peak Expiratory Flow (PEF) Morning | 7.47 L/min | Full Range -57 |
Secondary
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1236 | Vital Capacity (VC) | -0.025 L | Full Range -0.84 |
| Placebo | Vital Capacity (VC) | -0.043 L | Full Range -1.03 |