Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma

Study Overview
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Brief Summary
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The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week

Official Title
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A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler (SDDPI) vs. Placebo in Patients With Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: indacaterol maleate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 12 - 75 years of age with a diagnosis of persistent asthma Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent FEV1 at Visit 1 at least 50% of the predicted normal value FEV1 reversibility at least 15% Exclusion Criteria: Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years Chronic Obstructive Pulmonary Disease (COPD) Seasonal allergy where asthma is likely to deteriorate during the period of the study Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: indacaterol maleate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function measured 24 hours after having taken medication, by a special test called forced expiratory volume in 1 second (FEV1) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 at time points 30 min, 1, 2 and 4 h post-dose |  |  | 
| Percent change in FEV1 at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose |  |  | 
| Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, indacaterol, long acting β2-agonist