A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients With Bronchiectasis
Overview
- Phase
- Phase 2
- Intervention
- AZD9668
- Conditions
- Bronchiectasis
- Sponsor
- AstraZeneca
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female of non child bearing potential
- •Clinical diagnosis of bronchiectasis
- •Be sputum producers, with history of chronic expectoration on most days
Exclusion Criteria
- •Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
- •FEV1 of \<30% of predicted normal
Arms & Interventions
AZD9668 active treatment
Intervention: AZD9668
AZD9668 placebo treatment
Intervention: Placebo
Outcomes
Primary Outcomes
Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
Time Frame: 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
Slow Vital Capacity (SVC)
Time Frame: Baseline and day 28
Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28
Morning Peak Expiratory Flow (PEF)
Time Frame: Last 7 days on treatment
Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment
Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline
Time Frame: 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
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline and day 28
Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28
Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)
Time Frame: Baseline and day 28
FEF25-75% as a measure of lung function.Change from baseline to day 28
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
Time Frame: Baseline and day 28
SGRQ 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). Change from baseline to day 28.
Bronkotest Diary Card Signs and Symptoms
Time Frame: Last 7 days on treatment
The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.
24-hour Sputum Weight(g)
Time Frame: Baseline and day 28
Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28
Forced Vital Capacity (FVC)
Time Frame: Baseline and day 28
Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28
Evening Peak Expiratory Flow (PEF)
Time Frame: Last 7 days on treatment
Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment
Secondary Outcomes
- Ratio of Tumour Necrosis Factor Alpha (TNF α) 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 Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) 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 Interleukin 8 (IL-8) 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 Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline(Baseline and day 28)
- Ratio of Interleukin 6 (IL-6) 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 Interleukin 1 Beta (IL-1β) 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 Monocyte Chemoattractant Protein-1 (MCP-1) 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 Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline(Baseline and day 28)
- Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)