A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis
- Registration Number
- NCT00769119
- Lead Sponsor
- AstraZeneca
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Female of non child bearing potential
- Clinical diagnosis of bronchiectasis
- Be sputum producers, with history of chronic expectoration on most days
- Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
- FEV1 of <30% of predicted normal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD9668 placebo treatment Placebo - AZD9668 active treatment AZD9668 -
- Primary Outcome Measures
Name Time Method Ratio of Absolute Neutrophil Count 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
Slow Vital Capacity (SVC) 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) 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 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) 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%) 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) 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 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) Baseline and day 28 Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28
Forced Vital Capacity (FVC) 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) 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 Outcome Measures
Name Time Method 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 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) 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) 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 Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline Baseline and day 28 Ratio of day 28 to baseline
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 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) 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) 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 Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline Baseline and day 28 Ratio of day 28 to baseline
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. Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Trial Locations
- Locations (1)
Research Site
🇬🇧New Castle, United Kingdom