A 26-week Treatment, Multicenter, Randomized, Parallel Group, Blinded Study to Assess the Efficacy and Safety of QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Using Tiotropium Plus Formoterol as Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 934
- 试验地点
- 1
- 主要终点
- St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).
研究概览
简要总结
This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol 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
- Double (Participant, Investigator)
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
- •Male or female adults aged ≥ 40 yrs
- •Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)
- •Smoking history of at least 10 pack years
- •Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
排除标准
- •Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
- •Patients with a history of long QT syndrome
- •Patients with Type I or uncontrolled Type II diabetes
- •Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
- •Patients with any history of asthma
- •Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
- •Patients with concomitant pulmonary disease
- •Patients requiring long term oxygen therapy (>15 h a day)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
QVA149 plus placebo to tiotropium and placebo to formoterol
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
干预措施: QVA149 (Drug)
QVA149 plus placebo to tiotropium and placebo to formoterol
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
干预措施: Placebo to tiotropium (Drug)
QVA149 plus placebo to tiotropium and placebo to formoterol
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
干预措施: Placebo to formoterol (Drug)
Tiotropium plus Formoterol and placebo to QVA149
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
干预措施: Tiotropium (Drug)
Tiotropium plus Formoterol and placebo to QVA149
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
干预措施: Formoterol (Drug)
Tiotropium plus Formoterol and placebo to QVA149
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
干预措施: Placebo to QVA149 (Drug)
结局指标
主要结局
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).
时间窗: Baseline, week 26
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.
次要结局
- St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).(Baseline, week 26)
- Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.(Week 26)
- Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks(Week 26)
- Percent of Participants With at Least One Exacerbation Requiring Hospitalization(Week 26)
- Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period(Week 26)
- Trough FEV1 at Baseline and Week 26(Baseline, Week 26)
- FEV1 30 Min After the Morning Dose at Baseline and Week 26(Baseline, Week 26)
- Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C(Baseline, Week 26)