A Randomized, Double-blind, Parallel-group, 26-week Study Comparing the Efficacy and Safety of Indacaterol (Onbrez® Breezhaler® 150 mcg o.d.) With Salmeterol/Fluticasone Propionate (Seretide® Accuhaler® 50 mcg/500 mcg b.i.d.) in Patients With Moderate Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.
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 with moderate COPD (Stage II)
- •Able to perform spirometry assessments
- •Current or ex-smokers
- •On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1.
排除标准
- •Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
- •Having a history of, or current ECG abnormality
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Indacaterol
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
干预措施: Indacaterol (Drug)
Salmeterol/fluticasone propionate
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
干预措施: Salmeterol (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
时间窗: 12 weeks
Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.
次要结局
- Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'(26 weeks)
- St Georges Respiratory Questionnaire for COPD(12 and 26 weeks)
- Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons(26 weeks)
- FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons(12 weeks)
- FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons(26 weeks)
- FVC Over 26 Weeks of Treatment(12 and 26 weeks)
- Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison(12 and 26 weeks)
- TDI Focal Score at Week 12 and Week 26: Treatment Comparisons(12 and 26 weeks)
- Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)(26 weeks)
- Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment(12 and 26 weeks)