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Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.

NCT05342558 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2022-04-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fluticasone Furoate/Vilanterol 100/25 mcgs

Dry powder inhaler with 30 blisters. 100/25mcgs a day for 24 weeks.

DRUG

Umeclidinium/Vilanterol 62.5/25 mcgs

Dry powder inhaler with 30 blisters. 62.5/25mcgs a day for 24 weeks

Sponsors & Collaborators

  • National Institute of Respiratory Diseases, Mexico

    lead OTHER_GOV

Principal Investigators

  • Alejandra Ramírez-Venegas, M.S. · Instituto Nacional de Enfermedades Respiratorias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2020-11-19
Completion
2021-02-01

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05342558 on ClinicalTrials.gov