A Randomized, Multicenter, Open-label, Cross-over Study to Assess Lung Function and Patient Preference After a 4 Week Treatment Each With QVA149 vs. Tiotropium in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) and Moderate to Severe Airflow Limitation Who Are on a Tiotropium Therapy (FAVOR Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
研究概览
简要总结
The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed an Informed Consent Form
- •stable COPD according to current guidelines (GOLD 2013)
- •airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of ≥30% and <80% of predicted normal values at Visit
- •current or ex-smokers who have a smoking history of at least 10 pack years
- •Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1
- •Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).
排除标准
- •Pregnant or breast feeding mothers
- •Patients with conditions contraindicated for treatment
- •Patients with a history of clinically significant diseases
- •Patients who have a clinically significant renal disease
- •Patients with myocardial infarctions less than 6 months prior to study entry
- •Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
- •Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention
- •Patients with a history of malignancy of any organ system
- •Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening
- •Patients who have had a respiratory tract infection within 6 weeks prior to Screening
- •Patients with any history of asthma.
研究组 & 干预措施
Treatment sequence 1
QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
干预措施: QVA149 (Drug)
Treatment sequence 1
QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
干预措施: Tiotropium (Drug)
Treatment sequence 2
Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
干预措施: QVA149 (Drug)
Treatment sequence 2
Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
干预措施: Tiotropium (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
时间窗: week 4
Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
次要结局
- Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.(8 weeks)
- Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.(8 weeks)