Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol

Study Overview
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Brief Summary
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The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.

Official Title
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An Exploratory, Double-Blind Comparison of Inspiratory Capacity (IC) and FEV1 in COPD Patients Following Single Dose Administration of Indacaterol and Placebo and Open Label b.i.d. Administration of Formoterol

Conditions
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COPD

Intervention / Treatment
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* Drug: Indacaterol (QAB149)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and post-menopausal female adults aged 40-80 years inclusive. Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005) Smoking history of at least 10 pack years (either smokers or ex-smokers). Able to perform reproducible spirometry maneuvers. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent. Exclusion Criteria: COPD exacerbations within 6 weeks prior to dosing Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery. Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry. Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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 (QAB149)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent predicted FEV1 time course change over 24 hours |  |  | 
| Mean maximal change in IC time course change over 24 hours |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inspiratory capacity, FEV1, COPD