NCT02603393已完成4 期
A 26-week, Randomized, Double Blind, Parallel-group Multicenter Study to Assess the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,053
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Post-dose Trough FEV1
研究概览
简要总结
This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 who have signed Informed Consent Form prior to initiation of any study-related procedure.
- •Male and female adults aged ≥ 40 years.
- •Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.
- •Patients with a post-bronchodilator FEV1 ≥40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit
- •(Post refers to 15 min after inhalation of 400 µg of salbutamol).
- •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 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.
- •Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
排除标准
- •Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) .
- •Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit
- •Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
QVA149
Experimental
干预措施: QVA149 (Drug)
Tiotropium + salmeterol/fluticasone
Active Comparator
干预措施: Tiotropium (Drug)
Tiotropium + salmeterol/fluticasone
Active Comparator
干预措施: Salmeterol/fluticasone (Drug)
结局指标
主要结局
Mean Change From Baseline in Post-dose Trough FEV1
时间窗: Baseline, 26 weeks
Mean change from baseline in post-dose trough forced expiratory volume in 1 second (FEV1) following 26 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values measured at 23 hr 15 min and 23 hr 45 min after the morning dose taken at site on Day 181. Baseline FEV1 is defined as the average of the pre-dose FEV1 measured at -45 min and -15 min at Day 1.
次要结局
- Annualized Rate of Moderate or Severe COPD Exacerbations(26 weeks)
- Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only(26 weeks)
- Annualized Rate of COPD Exacerbations Requiring Hospitalisation(26 weeks)
- Mean Change From Baseline in Pre-dose Trough FEV1(26 weeks)
- Mean Change From Baseline in St. George's Respiratory Questionnaire(Baseline, 26 weeks)
- Transition Dyspnea Index (TDI) Score(26 weeks)
- Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication(Baseline, 26 weeks)
- Mean Change From Baseline in Forced Vital Capacity (FVC)(Baseline, 26 weeks)
研究者
研究点 (1)
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