Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

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

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Indacaterol 150 μg
* Drug: Tiotropium 18 μg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol 150 μg-tiotropium 18 μg-placebo<br>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. | Drug: Indacaterol 150 μg<br>* Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>Drug: Tiotropium 18 μg<br>* Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>Drug: Placebo<br>* Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>|
| Experimental: Tiotropium 18 μg-placebo-indacaterol 150 μg<br>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. | Drug: Indacaterol 150 μg<br>* Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>Drug: Tiotropium 18 μg<br>* Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>Drug: Placebo<br>* Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>|
| Experimental: Placebo-indacaterol 150 μg-tiotropium 18 μg<br>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. | Drug: Indacaterol 150 μg<br>* Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>Drug: Tiotropium 18 μg<br>* Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>Drug: Placebo<br>* Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After 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. | 4 hour period following inhalation of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 4 hour period following inhalation of study treatment | 
| Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After 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. | 4 hour period following inhalation of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, indacaterol, tiotropium