A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
- Registration Number
- NCT00757848
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) 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
- 56
- Male or post-menopausal or surgically sterile female patients
- Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal to 40% of normal
- Have normal renal function
- Lung transplant patients
- Significant liver disease
- Any other non-CF-related lung disease that may interfere with study assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD9668 AZD9668 - Placebo AZD9668 Placebo equivalent -
- Primary Outcome Measures
Name Time Method Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline Baseline and Values from day 21 to 28 Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits
Sputum Percentage Neutrophil Count Baseline and Values from day 21 to 28 Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)
24-hour Sputum Weight Baseline and day 28 Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.
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.
Slow Vital Capacity (SVC) Baseline and day 28 Slow Vital capacity (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% (L) as a measure of lung function. 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.
Morning Peak Expiratory Flow (PEF) Last 7 days on treatment Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment
Evening Peak Expiratory Flow (PEF) The last 7 days on treatment Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment
Bronkotest Diary Card Signs and Symptoms The 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.
Cystic Fibrosis Questionnaire (CFQ-R) - Quittner Baseline and day 28 Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.
- Secondary Outcome Measures
Name Time Method Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits
Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 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 Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28 Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits
Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits. Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits
Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits
Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits. Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits
Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 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
Trial Locations
- Locations (1)
Research Site
🇬🇧Liverpool, United Kingdom