A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 3
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment
研究概览
简要总结
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of asthma, and:
- •Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
- •Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
- •An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol
排除标准
- •Smoking history >10 pack-years
- •Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
- •Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
- •Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
- •Patients who have had an intubation for a severe asthma exacerbation
- •Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to screening
- •Patients who have had a respiratory tract infection within 6 weeks prior to screening
- •Patients with concomitant pulmonary disease
- •Patients with diabetes Type I or uncontrolled diabetes Type II
- •Any patient with lung cancer or a history of lung cancer
- •Patients with a history of certain cardiovascular comorbid conditions
- •Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Indacaterol 18.75 µg
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Indacaterol (Drug)
Indacaterol 18.75 µg
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to Salmeterol (Drug)
Indacaterol 37.5 µg
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Indacaterol (Drug)
Indacaterol 37.5 µg
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to Salmeterol (Drug)
Indacaterol 75 µg
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Indacaterol (Drug)
Indacaterol 75 µg
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to Salmeterol (Drug)
Indacaterol 150 µg
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Indacaterol (Drug)
Indacaterol 150 µg
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to Salmeterol (Drug)
Salmeterol
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Salmeterol (Drug)
Salmeterol
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to Indacaterol (Drug)
Placebo
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to Indacaterol (Drug)
Placebo
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
干预措施: Placebo to Salmeterol (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment
时间窗: Day 15 (after 2 weeks of treatment)
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
次要结局
- Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment(Day 2 (after 1 day of treatment))