Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, tolerability, inhalation
Brief summary
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
Interventions
DRUGAZD4818
Dry Powder, inhalation, b.i.d., 4 weeks
DRUGPlacebo
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
* Clinical diagnosis of COPD, with symptoms for more than 1 year * Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year) * Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Exclusion criteria
* Clinical suspicion of active tuberculosis * Any current clinically significant respiratory tract disorder other than COPD * History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Experiencing Adverse Events | At 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, 3 and 4 weeks of treatment | Change in FVC from baseline to end of treatment |
| Vital Capacity (VC) | Before treatment and after 1, 2, 3 and 4 weeks of treatment | Change in VC from baseline to end of treatment |
| Inspiratory Capacity (IC) | Before treatment and after 1, 2, 3 and 4 weeks of treatment | Change from IC baseline to end of treatment |
| Forced Expiratory Flow (FEF) 25%-75% | Before treatment and after 1, 2, 3 and 4 weeks of treatment | Change in FEF from baseline to end of treatment |
| Peak Expiratory Flow (PEF) Morning | Daily during run-in and treatment | Change from average during run-in to average during treatment |
| Peak Expiratory Flow (PEF) Evening | Daily during run-in and treatment | Change in PEF from average during run-in to average during treatment |
| Forced Expiratory Volume 1 (FEV1) | Before treatment and after 1, 2, 3 and 4 weeks of treatment | Change in (FEV1) from baseline to end of treatment |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Daily during run-in and treatment | Change 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). |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Daily during run-in and treatment | Change 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). |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Daily during run-in and treatment | Change 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). |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score | Daily during run-in and treatment | Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). |
| 6-minute Walk Test | Before treatment and after 4 weeks of treatment | Change from baseline to end of treatment |
| The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total | Before treatment and after 1, 2, 3 and 4 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
Denmark, Finland, Netherlands, Norway, Sweden
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| AZD4818 AZD4818 Turbuhaler | 33 |
| Placebo Placebo | 32 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | AZD4818 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 65 years | 66 years | 65 years |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 23 Participants | 24 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 33 | 22 / 32 |
| serious Total, serious adverse events | 2 / 33 | 0 / 32 |
Outcome results
Primary
Number of Patients Experiencing Adverse Events
Number of patients who had an Adverse Event
Time frame: At all study visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD4818 | Number of Patients Experiencing Adverse Events | 22 Participants |
| Placebo | Number of Patients Experiencing Adverse Events | 27 Participants |
Secondary
6-minute Walk Test
Change from baseline to end of treatment
Time frame: Before treatment and after 4 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | 6-minute Walk Test | -8.67 meter | Full Range -163 |
| Placebo | 6-minute Walk Test | -6.67 meter | Full Range -125 |
Secondary
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Change 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).
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | 0.159 Scores on a scale | Full Range -0.446 |
| Placebo | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | -0.007 Scores on a scale | Full Range -1.18 |
Secondary
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Change 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).
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | 0.170 Score on a scale | Full Range -0.823 |
| Placebo | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | 0.024 Score on a scale | Full Range -0.807 |
Secondary
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Change 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).
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | 0.064 Scores on a scale | Full Range -0.431 |
| Placebo | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | -0.103 Scores on a scale | Full Range -1.91 |
Secondary
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AZD4818 | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score | 0.085 Scores on a scale |
| Placebo | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score | 0.000 Scores on a scale |
Secondary
Forced Expiratory Flow (FEF) 25%-75%
Change in FEF from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Forced Expiratory Flow (FEF) 25%-75% | -0.027 L/s | Full Range -0.19 |
| Placebo | Forced Expiratory Flow (FEF) 25%-75% | 0.006 L/s | Full Range -0.49 |
Secondary
Forced Expiratory Volume 1 (FEV1)
Change in (FEV1) from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Forced Expiratory Volume 1 (FEV1) | -0.083 L | Full Range -0.5 |
| Placebo | Forced Expiratory Volume 1 (FEV1) | -0.149 L | Full Range -1.05 |
Secondary
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Forced Vital Capacity (FVC) | -0.044 L | Full Range -1.02 |
| Placebo | Forced Vital Capacity (FVC) | -0.240 L | Full Range -1.54 |
Secondary
Inspiratory Capacity (IC)
Change from IC baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Inspiratory Capacity (IC) | -0.117 L | Full Range -1.02 |
| Placebo | Inspiratory Capacity (IC) | -0.038 L | Full Range -0.73 |
Secondary
Peak Expiratory Flow (PEF) Evening
Change in PEF from average during run-in to average during treatment
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AZD4818 | Peak Expiratory Flow (PEF) Evening | -12.4 L/min |
| Placebo | Peak Expiratory Flow (PEF) Evening | -1.90 L/min |
Secondary
Peak Expiratory Flow (PEF) Morning
Change from average during run-in to average during treatment
Time frame: Daily during run-in and treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Peak Expiratory Flow (PEF) Morning | -9.10 L/min | Full Range -62.8 |
| Placebo | Peak Expiratory Flow (PEF) Morning | -4.47 L/min | Full Range -43.3 |
Secondary
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) 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, 3 and 4 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total | 0.250 Score on a scale | Full Range -1.08 |
| Placebo | The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total | 0.044 Score on a scale | Full Range -1.58 |
Secondary
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD4818 | Vital Capacity (VC) | -0.022 L | Full Range -0.86 |
| Placebo | Vital Capacity (VC) | -0.022 L | Full Range -1.25 |