A Randomized, Double-blind Placebo-controlled Study to Compare the Efficacy of Indacaterol With That of Placebo in Patients With COPD Who Have Not Previously Received Maintenance COPD Medication, Using Blinded Tiotropium as Active Control
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Efficacy comparison of indacaterol to placebo
研究概览
简要总结
This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).
详细描述
The purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD 2011 Groups A and B.
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 stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD
- •Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and <80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7
- •Patients with no record of receipt of maintenance medication for COPD.
- •Patients with a mMRC dyspnea score ≥1 at Visit
- •Current or ex-smokers who have a smoking history of at least 10 pack years.
排除标准
- •Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
- •Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit
- •Patients who have had a respiratory tract infection.
- •Patients requiring long-term oxygen therapy (>12 hours a day) on a daily basis.
- •Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years.
- •Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids intermittently. Treatment with a stable dose is permitted.
- •Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Indacaterol
Indacaterol once daily
干预措施: Indacaterol (Drug)
Indacaterol
Indacaterol once daily
干预措施: Placebo to indacaterol (Drug)
Placebo
Placebo for indacaterol and placebo for tiotropium once daily
干预措施: Placebo to tiotropium (Drug)
Placebo
Placebo for indacaterol and placebo for tiotropium once daily
干预措施: Placebo to indacaterol (Drug)
Tiotropium
Tiotropium
干预措施: Placebo to tiotropium (Drug)
Tiotropium
Tiotropium
干预措施: Tiotropium (Drug)
结局指标
主要结局
Efficacy comparison of indacaterol to placebo
时间窗: 12 weeks
Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment.
次要结局
- St George's Respiratory Questionnaire for COPD total score comparison between treatments(12 weeks)
- Adverse events and serious adverse events for all treatment groups(week 12)
- St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments(12 weeks)
- Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups(12 weeks)