Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

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 COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- 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 vs. Placebo in Patients With Moderate to Severe COPD.

Conditions
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Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive

Intervention / Treatment
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* Drug: indacaterol maleate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath. Smoking history of at least 10 pack years FEV1 less than 65% of the predicted normal value and at least 0.75 L Pre-bronchodilator FEV1/FVC less than 70% Exclusion Criteria: A history of asthma or COPD diagnosis before the age of 40 Hospitalization for COPD exacerbation within the previous 6 weeks Respiratory tract infection within 6 weeks Use of long-term oxygen therapy Diabetes type I or uncontrolled diabetes type II Clinically relevant laboratory abnormality or clinically significant condition Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 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: Crossover 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 4hours post-dose |  |  | 
| Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose |  |  | 
| Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose |  |  | 
| Standardized FEV1 area under the curve (AUC) between baseline and 4 hours |  |  | 

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