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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Ratio of 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 Bronchiectasis (Brx) 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female of non child bearing potential
- •Clinical diagnosis of bronchiectasis
- •Be sputum producers, with history of chronic expectoration on most days
排除标准
- •Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
- •FEV1 of <30% of predicted normal
研究组 & 干预措施
AZD9668 active treatment
干预措施: AZD9668 (Drug)
AZD9668 placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
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
Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: Baseline and day 28
Sputum weight (g) collected during 24 hour periods.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
Evening Peak Expiratory Flow (PEF)
时间窗: 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
次要结局
- 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.)