Efficacy in Walked Distance of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass (EMERALD)
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico