MOVE - A Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo
研究概览
简要总结
This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..
- •Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70
排除标准
- •Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.
- •Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min.
- •Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
- •Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
- •Patients with a body mass index (BMI) of more than 40 kg/m
- •Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
- •Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.
- •Patients who have had a respiratory tract infection within 4 weeks prior to screening.
- •Patients with any history of asthma. Patients with concomitant pulmonary disease Patients with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Treatment sequence II
Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days
干预措施: Placebo (Drug)
Treatment sequence I
QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days
干预措施: Placebo (Drug)
Treatment sequence I
QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days
干预措施: QVA149 (Drug)
Treatment sequence II
Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days
干预措施: QVA149 (Drug)
结局指标
主要结局
Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo
时间窗: Baseline, day 22, baseline day 36, day 57
Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level
时间窗: Baseline, day 22, baseline day 36, day 57
Average physical activity level is defined by average daily activity-related energy consumption \[Kcal/day\], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
次要结局
- Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day(Baseline, day 22, baseline day 36, day 57)
- Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo(Baseline, day 22, baseline day 36, day 57)
- Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.(Day 1 or day 36)
- Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo(Baseline, day 22, baseline day 36, day 57)
- Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1(Day 1 or day 36)
- Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days(Baseline, day 22, baseline day 36, day 57)