Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
This is a randomized, blinded, controlled clinical trial for mexican COPD patients.
Biomass smoke associated COPD (BS-COPD) clinical spectrum is different to the one seen in
tobacco smoke associated COPD (TS-COPD). BS-COPD patients present COPD-asthma phenotype or
asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype.
BS-COPD patients have a greater risk of exacerbations in comparison to the emphysema
phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among
the clinical practitioners.
The investigators expect treatment with FF/V to be superior in preventing COPD exacerbations
than the U/V combination in patients with COPD-asthma phenotype; andU/V to be superior than
FF/V in patients with the emphysema phenotype.
The general objective of the study is to determine the exacerbations outcome in patients with
COPD-asthma vs emphysema phenotype patients, treated with both drugs. Secondary objectives
include assessment of pulmonary function tests, quality of life, dyspnea and functional
capacity change after a 24 weeks treatment.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico