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 Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Lung transplant patients
- •Significant liver disease
- •Any other non-CF-related lung disease that may interfere with study assessments
研究组 & 干预措施
AZD9668
干预措施: AZD9668 (Drug)
Placebo
干预措施: AZD9668 Placebo equivalent (Drug)
结局指标
主要结局
Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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%)
时间窗: Baseline and day 28
FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.
Forced Vital Capacity (FVC)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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 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 Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline(Baseline and day 28)
- 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 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 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 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 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 Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline(Baseline and day 28)