Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Indacaterol 150 μg
Drug: Tiotropium 18 μg
Drug: Placebo

Registration Number: NCT00999908

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

Inclusion Criteria

Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
1. Smoking history of at least 10 pack-years.
2. Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
3. Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indacaterol 150 μg-tiotropium 18 μg-placebo	Indacaterol 150 μg	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.
Placebo-indacaterol 150 μg-tiotropium 18 μg	Indacaterol 150 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.
Indacaterol 150 μg-tiotropium 18 μg-placebo	Tiotropium 18 μg	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.
Tiotropium 18 μg-placebo-indacaterol 150 μg	Tiotropium 18 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.
Tiotropium 18 μg-placebo-indacaterol 150 μg	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.
Indacaterol 150 μg-tiotropium 18 μg-placebo	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.
Tiotropium 18 μg-placebo-indacaterol 150 μg	Placebo	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.
Placebo-indacaterol 150 μg-tiotropium 18 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.
Placebo-indacaterol 150 μg-tiotropium 18 μg	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment	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.

Secondary Outcome Measures

Name	Time	Method
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	FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
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	FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.