Bronchiectasis, Lung Disease, Respiratory Diseases
Conditions
Keywords
Bronchiectasis, Neutrophil, Respiratory disease, Sputum
Brief summary
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.
Interventions
DRUGAZD5069
Oral dose bid
DRUGPlacebo
Oral dose bid
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal. * Aged 18 to 80 years inclusive at screening (Visit 1) * Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram * Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more. * Be on a stable treatment regimen, as judged by the investigator.
Exclusion criteria
* Any clinically significant disease or disorder * Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2 * An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2 * An FEV1 of \<30% of predicted normal at Visit 1 * Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2) * Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis * Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weight of 24-hour Sputum Collection | Baseline and end of treatment (Day 28) | Patients collected all sputum produced during a 24-hour period at baseline and Day 28. |
| Change From Baseline in Slow Vital Capacity (SVC) | Baseline to end of treatment (Day 28) | Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration. |
| Change From Baseline in Forced Vital Capacity (FVC) | Baseline to end of treatment (Day 28) | Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver. |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline to end of treatment (Day 28) | Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration. |
| Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75) | Baseline to end of treatment (Day 28) | Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled). |
| Transition Dyspnea Index (TDI) at End of Treatment (Day 28) | Baseline to end of treatment (Day 28) | TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea. |
| Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card | Baseline and Last 7 days on treatment | The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement. |
| Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Baseline and Last 7 days on treatment | The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement. |
| Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Baseline and end of treatment (Day 28) | SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains: Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status). |
| Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
| Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits. |
Countries
Czechia, Poland, United Kingdom
Participant flow
Recruitment details
This multicenter study was conducted in Europe between 27 December 2010 and 13 February 2012.
Participants by arm
| Arm | Count |
|---|---|
| AZD5069 AZD5069 80 mg bd | 26 |
| Placebo Placebo bd | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | AZD5069 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 6.6 | 65 years STANDARD_DEVIATION 8.8 | 65 years STANDARD_DEVIATION 7.7 |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 26 participants | 26 participants | 52 participants |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 26 | 16 / 26 |
| serious Total, serious adverse events | 1 / 26 | 0 / 26 |
Outcome results
Primary
Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline | 0.31 ratio | 90% Confidence Interval 165.925 |
| Placebo | Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline | 1.00 ratio | 90% Confidence Interval 213.281 |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.p-value: 0.00490% CI: [0.17, 0.59]ANCOVA
Secondary
Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card
The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.
Time frame: Baseline and Last 7 days on treatment
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD5069 | Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card | Morning PEF | -5.3 L/min | Standard Error 5.41 |
| AZD5069 | Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card | Evening PEF | -7.3 L/min | Standard Error 4.95 |
| Placebo | Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card | Morning PEF | -5.9 L/min | Standard Error 5.53 |
| Placebo | Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card | Evening PEF | -10.6 L/min | Standard Error 5.06 |
Comparison: Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.93590% CI: [-12.81, 14.13]ANCOVA
Comparison: Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.65490% CI: [-9.02, 15.64]ANCOVA
Secondary
Change From Baseline for the Symptom Scores of the Bronkotest Diary Card
The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.
Time frame: Baseline and Last 7 days on treatment
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Describe your breathing | 0.1 units on a scale | Standard Error 0.1 |
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | How often do you cough? | 0.1 units on a scale | Standard Error 0.09 |
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Night time symptom score | 0.4 units on a scale | Standard Error 0.12 |
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | What color is your sputum? | -0.7 units on a scale | Standard Error 0.18 |
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | The amount of sputum you produced | 0.1 units on a scale | Standard Error 0.08 |
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Type of sputum | -0.3 units on a scale | Standard Error 0.09 |
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | How do you feel? | 0.2 units on a scale | Standard Error 0.1 |
| AZD5069 | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Number of puffs of inhalers | 0.1 units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Number of puffs of inhalers | 0.2 units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Describe your breathing | -0.1 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | The amount of sputum you produced | 0.0 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | How often do you cough? | 0.0 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | How do you feel? | -0.0 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Night time symptom score | 0.1 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | Type of sputum | -0.1 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline for the Symptom Scores of the Bronkotest Diary Card | What color is your sputum? | -0.3 units on a scale | Standard Error 0.18 |
Comparison: Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.32990% CI: [-0.09, 0.36]ANCOVA
Comparison: How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.66490% CI: [-0.16, 0.27]ANCOVA
Comparison: Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.15290% CI: [-0.04, 0.54]ANCOVA
Comparison: What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.1590% CI: [-0.8, 0.05]ANCOVA
Comparison: The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.24890% CI: [-0.06, 0.35]ANCOVA
Comparison: Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.05390% CI: [-0.45, -0.04]ANCOVA
Comparison: How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.17990% CI: [-0.04, 0.42]ANCOVA
Comparison: Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.94290% CI: [-0.75, 0.68]ANCOVA
Secondary
Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).
Time frame: Baseline to end of treatment (Day 28)
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75) | -0.04 liters/second | Standard Error 0.063 |
| Placebo | Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75) | -0.07 liters/second | Standard Error 0.062 |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.79190% CI: [-0.13, 0.17]ANCOVA
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.
Time frame: Baseline to end of treatment (Day 28)
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | -0.01 liters | Standard Error 0.044 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | -0.01 liters | Standard Error 0.043 |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.96690% CI: [-0.11, 0.1]ANCOVA
Secondary
Change From Baseline in Forced Vital Capacity (FVC)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.
Time frame: Baseline to end of treatment (Day 28)
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Change From Baseline in Forced Vital Capacity (FVC) | 0.07 liters | Standard Error 0.056 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | 0.06 liters | Standard Error 0.054 |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.92990% CI: [-0.12, 0.14]ANCOVA
Secondary
Change From Baseline in Slow Vital Capacity (SVC)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.
Time frame: Baseline to end of treatment (Day 28)
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Change From Baseline in Slow Vital Capacity (SVC) | 0.05 liters | Standard Error 0.067 |
| Placebo | Change From Baseline in Slow Vital Capacity (SVC) | -0.05 liters | Standard Error 0.063 |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.28490% CI: [-0.05, 0.26]ANCOVA
Secondary
Change From Baseline in Weight of 24-hour Sputum Collection
Patients collected all sputum produced during a 24-hour period at baseline and Day 28.
Time frame: Baseline and end of treatment (Day 28)
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Change From Baseline in Weight of 24-hour Sputum Collection | 3.51 grams | Standard Error 2.455 |
| Placebo | Change From Baseline in Weight of 24-hour Sputum Collection | -3.26 grams | Standard Error 2.195 |
Comparison: The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.p-value: 0.04790% CI: [1.22, 12.33]ANCOVA
Secondary
Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains: Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status).
Time frame: Baseline and end of treatment (Day 28)
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD5069 | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Total score | -1.75 units on a scale | Standard Error 2.402 |
| AZD5069 | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Symptom domain | -3.16 units on a scale | Standard Error 2.356 |
| AZD5069 | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Activity domain | -0.46 units on a scale | Standard Error 3.216 |
| AZD5069 | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Impact domain | -1.83 units on a scale | Standard Error 2.742 |
| Placebo | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Impact domain | -1.45 units on a scale | Standard Error 2.689 |
| Placebo | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Total score | -0.09 units on a scale | Standard Error 2.355 |
| Placebo | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Activity domain | 0.85 units on a scale | Standard Error 3.153 |
| Placebo | Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) | Symptom domain | 1.72 units on a scale | Standard Error 2.309 |
Comparison: Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.62590% CI: [-7.32, 4]ANCOVA
Comparison: Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.15190% CI: [-10.49, 0.74]ANCOVA
Comparison: Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.77390% CI: [-8.91, 6.28]ANCOVA
Comparison: Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.9290% CI: [-6.84, 6.07]ANCOVA
Secondary
Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline | 1.28 ratio |
| Placebo | Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline | 0.83 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.11290% CI: [0.98, 2.4]ANCOVA
Secondary
Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline | 5.45 ratio |
| Placebo | Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline | 0.99 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: <0.00190% CI: [4.18, 7.23]ANCOVA
Secondary
Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline | 2.77 ratio |
| Placebo | Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline | 0.85 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: <0.00190% CI: [2.19, 4.79]ANCOVA
Secondary
Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline | 1.45 ratio |
| Placebo | Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline | 0.93 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.00190% CI: [1.28, 1.91]ANCOVA
Secondary
Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline | 0.63 ratio |
| Placebo | Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline | 0.91 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.2290% CI: [0.42, 1.14]ANCOVA
Secondary
Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline | 1.13 ratio |
| Placebo | Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline | 0.97 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.28190% CI: [0.92, 1.47]ANCOVA
Secondary
Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline | 3.68 ratio |
| Placebo | Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline | 0.82 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: <0.00190% CI: [3.05, 6.54]ANCOVA
Secondary
Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline | 5.90 ratio |
| Placebo | Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline | 0.97 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: <0.00190% CI: [4.42, 8.35]ANCOVA
Secondary
Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline | 0.81 ratio |
| Placebo | Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline | 0.80 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.91790% CI: [0.71, 1.48]ANCOVA
Secondary
Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline | 0.91 ratio |
| Placebo | Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline | 0.92 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.96890% CI: [0.78, 1.27]ANCOVA
Secondary
Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline | 0.34 ratio |
| Placebo | Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline | 1.95 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.11190% CI: [0.03, 1.08]ANCOVA
Secondary
Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline | 0.99 ratio |
| Placebo | Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline | 1.07 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.6790% CI: [0.68, 1.26]ANCOVA
Secondary
Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline | 1.18 ratio |
| Placebo | Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline | 0.89 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.36790% CI: [0.79, 2.26]ANCOVA
Secondary
Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline | 0.66 ratio | 90% Confidence Interval 29.746 |
| Placebo | Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline | 1.02 ratio | 90% Confidence Interval 56.883 |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.p-value: 0.00890% CI: [0.49, 0.84]ANCOVA
Secondary
Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline | 1.02 ratio |
| Placebo | Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline | 0.97 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.24190% CI: [0.98, 1.12]ANCOVA
Secondary
Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Population: The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| AZD5069 | Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline | 1.29 ratio |
| Placebo | Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline | 0.91 ratio |
Comparison: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.p-value: 0.19390% CI: [0.91, 2.24]ANCOVA
Secondary
Transition Dyspnea Index (TDI) at End of Treatment (Day 28)
TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.
Time frame: Baseline to end of treatment (Day 28)
Population: The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD5069 | Transition Dyspnea Index (TDI) at End of Treatment (Day 28) | -1 units on a scale | Standard Error 0.5 |
| Placebo | Transition Dyspnea Index (TDI) at End of Treatment (Day 28) | -0 units on a scale | Standard Error 0.5 |
Comparison: The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.p-value: 0.43390% CI: [-1.6, 0.6]ANCOVA