A Randomized, Double-blind, Placebo-controlled, Two-period Crossover Study to Assess the Effect of Inhaled QVA149 on Global and Regional Lung Function and Gas Exchange in Patients With Moderate to Severe COPD
概览
- 阶段
- 4 期
- 干预措施
- QVA149
- 疾病 / 适应症
- Chronic Obstructive Pulmonary Disease
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Global Ventilated Lung Volume
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
The purpose of this study was to assess global ventilated lung volume in moderate to severe COPD patients using MRI lung imaging after treatment with QVA149 compared to placebo.
详细描述
The MRI approach represented an opportunity to better understand the impact of a potent dual bronchodilator on the small and central airways and thereby increasing ventilated lung volume, gas exchange, and ventilation-perfusion deficits. The study investigated the effect of QVA149 on global and regional lung ventilation using MRI lung imaging to enhance the understanding of QVA pharmacology in COPD patients.
研究者
入排标准
入选标准
- •Males and females with COPD aged 40 years and above, weighing ≥45 kg and ≤100 kg, who were smokers and ex-smokers who had a smoking history of at least 10 pack years, and diagnosed with moderate to severe COPD according to GOLD 2015 criteria were included in the study. Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC \< 0.70 and by a post-bronchodilator FEV1 ≥ 30 % and \<80 % were included in the study. Post-bronchodilator refers to 1 hr (+/- 5 minutes) after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol/360 µg albuterol (or equivalent dose).
排除标准
- •Patients with conditions which could compromise patient safety and compliance (as judged by the investigator), as well as conditions that required oxygen therapy for chronic hypoxemia, ≥25% emphysematous changes on a scan within 6 months to screening, those with lower respiratory infections within 6 weeks of screening, and patients with concomitant pulmonary disease were excluded from the study. Patients with asthma were also excluded from the study.
- •Pregnant or nursing (lactating) women, patients with poorly controlled Type I or Type II diabetes, patients with poor renal function, and those who were unable to use a dry powder inhaler or perform spirometry, and had contraindications to MRI were also excluded.
研究组 & 干预措施
QVA149 110/50 mcg then Matching placebo
Single daily dose of 110/50 μg QVA149 for 8-10 days.
干预措施: QVA149
Matching placebo then QVA149 110/50 mcg
Single daily dose of matching placebo for 8-10 days.
干预措施: QVA149
Matching placebo then QVA149 110/50 mcg
Single daily dose of matching placebo for 8-10 days.
干预措施: Placebo
结局指标
主要结局
Global Ventilated Lung Volume
时间窗: Day 8 to Day 10 (each treatment period)
The global distribution of inhaled gas within the lung was assessed using an inhaled gaseous contrast agent, Hyperpolarized Helium (3He) Lung Imaging. The Global Ventilated Lung Volume was expressed in percentage (%VV) of total lung volume.
次要结局
- Forced Expiratory Volume in 1 Second (FEV1)(Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period))
- Lung Clearance Index by Multiple Breath Nitrogen Washout (MBNW)(Day 8 (each treatment period))
- Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(Day 8 (each treatment period))
- Regional Ventilated Lung Volume(Day 8 to Day 10 (each treatment period))
- FEV1/FVC Ratio(Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period))
- Pulmonary Perfusion(Day 8 to Day 10 (each treatment period))
- Forced Vital Capacity (FVC)(Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period))