Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

Study Overview
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Brief Summary
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This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as maintenance naïve, see inclusion criteria).

Detailed Description
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The purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD 2011 Groups A and B.

Official Title
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A Randomized, Double-blind Placebo-controlled Study to Compare the Efficacy of Indacaterol With That of Placebo in Patients With COPD Who Have Not Previously Received Maintenance COPD Medication, Using Blinded Tiotropium as Active Control

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Indacaterol
* Drug: Placebo to tiotropium
* Drug: Tiotropium
* Drug: Placebo to indacaterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD 2011. Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and <80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7 Patients with no record of receipt of maintenance medication for COPD. Patients with a mMRC dyspnea score ≥1 at Visit 2. Current or ex-smokers who have a smoking history of at least 10 pack years. Exclusion Criteria: Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability. Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit 1. Patients who have had a respiratory tract infection. Patients requiring long-term oxygen therapy (>12 hours a day) on a daily basis. Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years. Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids intermittently. Treatment with a stable dose is permitted. Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis 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 once daily | Drug: Indacaterol<br>* Indacaterol once daily via single-dose dry powder inhaler<br>Drug: Placebo to indacaterol<br>* Placebo to indacaterol capsules for inhalation once daily<br>|
| Placebo Comparator: Placebo<br>Placebo for indacaterol and placebo for tiotropium once daily | Drug: Placebo to tiotropium<br>* Placebo to tiotropium capsules for inhalation once daily<br>Drug: Placebo to indacaterol<br>* Placebo to indacaterol capsules for inhalation once daily<br>|
| Active Comparator: Tiotropium<br>Tiotropium | Drug: Placebo to tiotropium<br>* Placebo to tiotropium capsules for inhalation once daily<br>Drug: Tiotropium<br>* Tiotropium capsules for inhalation once daily<br>* Other names: Tiotropium 18 mcg od via single-dose dry powder inhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy comparison of indacaterol to placebo | Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments | Effects comparison of indacaterol to placebo in terms of the patient-centric measurement St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment. | 12 weeks | 
| Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups | Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second. | 12 weeks | 
| St George's Respiratory Questionnaire for COPD total score comparison between treatments | Effects comparison of indacaterol to tiotropium in terms of St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment. | 12 weeks | 
| Adverse events and serious adverse events for all treatment groups | All adverse events will be reported | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Chronic obstructive pulmonary disease, indacaterol, tiotropium