Efficacy of Indacaterol 150 µg Versus Formoterol

Study Overview
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Brief Summary
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The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1). Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.

Official Title
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A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Indacaterol
* Drug: Formoterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and: Post-bronchodilator FEV1 <80% and ≥40% of the predicted normal value Post-bronchodilator FEV1/FVC (forced vital capacity) <70% Smoking history of at least 10 pack-years Exclusion Criteria: Patients who have had a COPD exacerbation 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 a history of asthma Patients with diabetes Type I or uncontrolled diabetes Type II Any patient with lung cancer or a history of lung cancer Patients with a history of certain cardiovascular comorbid conditions Other protocol-defined inclusion/exclusion criteria may apply

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol<br>Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI) | Drug: Indacaterol<br>* Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)<br>|
| Active Comparator: Formoterol<br>Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI) | Drug: Formoterol<br>* Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-h post-dose trough forced expiratory volume in 1 second (FEV1) |  | After 84 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-h post-dose trough inspiratory capacity (IC) |  | After 84 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Indacaterol, Formoterol