Efficacy and Acute Effects on Walked Distance froM basEline and Post Dose of indacateRol vs Tiotropium in Women With modeRAte to Severe COPD Secondary to Biomass Exposure: Open Label Crossover Clinical Trial

Detailed Summary

Chronic Obstructive Pulmonary Disease (COPD) secondary to biomass exposure constitutes a chronic respiratory condition frequently excluded from large clinical trials. Biomass exposure COPD have some histopathologic, clinical, radiological and functional differences with tobacco smoke COPD. However, until now, there are no evidence in this patients about the clinical response to bronchodilators routinely used in tobacco smoke COPD. Primary objective: To compare changes in walked meters from baseline on six minute walking test (6MWT) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate to severe COPD secondary to biomass exposure. Secondary objectives: To compare changes in pulmonary function (inspiratory capacity, Forced Expiratory Volume in first second (FEV1) milliliters, FEV1 "through") from baseline (-10 minutes) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate to severe COPD secondary to biomass exposure. This will be an open label study, double blinded, cross over and conducted at specialized respiratory care center (National Institute of Respiratory Diseases), to compare the acute effects of ultra long acting bronchodilators used in tobacco smoke exposure COPD. Unicentric study. Ethics Committee approbation: C 22-12

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