12-week Open-label Evaluation of Efficacy and Safety of Indacaterol

Study Overview
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Brief Summary
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In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.

Official Title
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A 12 Week, Multi-center, Randomized, Open Label Study, eValuating the Efficacy and Safety of Treatment Regimens That Include ONbrez (Indacaterol) in Patients With Moderate to Severe COPD (MOVE-ON Study)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Indacaterol
* Drug: Long-acting beta2-agonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and: Post-bronchodilator forced expiratory volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS) Exclusion Criteria: Patients with a history of asthma Patients who are currently being treated for COPD with tiotropium (Spiriva®) Patients with diabetes Type I or uncontrolled diabetes Type II 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol<br>Indacaterol 150 µg once-daily via single-dose dry powder inhaler | Drug: Indacaterol<br>* Indacaterol 150 µg once-daily via single-dose dry powder inhaler<br>|
| Active Comparator: Long-acting beta2-agonist<br>Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy | Drug: Long-acting beta2-agonist<br>* Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same. | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indacaterol, COPD, Long-acting beta2-agonist (LABA)