A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)
研究概览
简要总结
To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
- •Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
- •Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
- •Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
- •ACQ-5 score ≥ 1.5
排除标准
- •Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- •Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
- •Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
indacaterol acetate 75 µg
indacaterol acetate 75 µg od delivered via Concept 1 inhaler
Background therapy: mometasone furoate 200 mcg od
干预措施: indacaterol (Drug)
indacaterol acetate 75 µg
indacaterol acetate 75 µg od delivered via Concept 1 inhaler
Background therapy: mometasone furoate 200 mcg od
干预措施: mometasone furoate (Drug)
indacaterol acetate 150 µg
indacaterol acetate 150 µg od delivered via Concept 1 inhaler
Background therapy: mometasone furoate 200 mcg od
干预措施: indacaterol (Drug)
indacaterol acetate 150 µg
indacaterol acetate 150 µg od delivered via Concept 1 inhaler
Background therapy: mometasone furoate 200 mcg od
干预措施: mometasone furoate (Drug)
placebo
placebo delivered via Concept 1 inhaler
Background therapy: mometasone furoate 200 mcg od
干预措施: placebo (Drug)
placebo
placebo delivered via Concept 1 inhaler
Background therapy: mometasone furoate 200 mcg od
干预措施: mometasone furoate (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)
时间窗: after 12 weeks (Day 85)
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)
次要结局
- Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.(Day 15, Day 29 and Day 57)
- Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points(Day 1, Day 2, Day 14, Day 15, Day 84, Day 85)
- Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85(Day 1, Day 2, Day 14, Day 15, Day 84, Day 85)
- Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85(Day 1, Day 2, Day 14, Day 15, Day 84, Day 85)
- Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)(Day 1, 2 Weeks, 12 Weeks)
- Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)(Day 1, 2 weeks (Day 14), 12 weeks (Day 84))
- Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment(after 4 weeks (Day 29) and after 8 weeks (Day 57))
- Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.(baseline, 4weeks, 8 weeks and 12 weeks)
- The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment(12 weeks)
- Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment(4 Weeks, 12 Weeks)
- Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)(aftert 12 weeks (Day 85))
- Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period(12 weeks)
- The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period(12 weeks)
- Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period(12 weeks)
- The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period(12 weeks)
- Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period(12 weeks)
- The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period(12 weeks)
- Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period(12 weeks)
- Plasma Indacaterol Concentrations at Day 1 and Day 14(Day 1 and Day 14)