Status:
COMPLETED
Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Type and duration of the investigation: A randomized, blinded, controlled clinical trial; longitudinal, prospective, 3 years (Sep-2017 through Sep-2020). Background: COPD associated to biomass smoke ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT05342558
Start Date
September 19 2017
End Date
February 1 2021
Last Update
April 22 2022
Active Locations (1)
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1
National Institute of Respiratory Diseases 'Ismael Cosío Villegas'
Mexico City, Tlalpan, Mexico, 14080