Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
研究概览
简要总结
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
- •Smoking history of at least 10 pack-years.
- •Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
- •Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.
排除标准
- •Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 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 alpha-1-antitrypsin deficiency.
- •Patients with contraindications for tiotropium treatment.
- •Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Indacaterol 150 μg-tiotropium 18 μg-placebo
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Indacaterol 150 μg (Drug)
Indacaterol 150 μg-tiotropium 18 μg-placebo
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Tiotropium 18 μg (Drug)
Indacaterol 150 μg-tiotropium 18 μg-placebo
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Placebo (Drug)
Tiotropium 18 μg-placebo-indacaterol 150 μg
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Indacaterol 150 μg (Drug)
Tiotropium 18 μg-placebo-indacaterol 150 μg
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Tiotropium 18 μg (Drug)
Tiotropium 18 μg-placebo-indacaterol 150 μg
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Placebo (Drug)
Placebo-indacaterol 150 μg-tiotropium 18 μg
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Indacaterol 150 μg (Drug)
Placebo-indacaterol 150 μg-tiotropium 18 μg
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Tiotropium 18 μg (Drug)
Placebo-indacaterol 150 μg-tiotropium 18 μg
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
时间窗: 4 hour period following inhalation of study treatment
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
次要结局
- Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment(4 hour period following inhalation of study treatment)
- Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment(4 hour period following inhalation of study treatment)