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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Respiratory Diseases, Mexico
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Patients aged 40 to 80 years

• Men and women (not fertile, not pregnant, or those with a effective birth control method)

• COPD diagnosis according to GOLD 2017 criteria with a FEV1 ≥ 30%

• Biomass smoke exposition index ≥ 100 hours/year or smoking index ≥ 10 packs/year,

• Patients with at least two exacerbations in the last 12 months (confirmed by the prescription of antibiotic and/or oral steroid)

• Patients with stable COPD (no exacerbations or respiratory infections in the 4 weeks prior inclusion).

Exclusion Criteria:

• Patients with allergies or intolerance to study medications

• Female patients on pregnancy, lactancy

• Patients with cancer diagnosis

• Patients with bronchiectasis, tuberculosis, recent COPD exacerbation, or any respiratory infection or cardiovascular anomaly that withholds the respiratory function test