Status:
RECRUITING
Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico
Conditions:
COPD Bronchitis
Pollution Related Respiratory Disorder
Eligibility:
FEMALE
35-85 years
Phase:
PHASE4
Brief Summary
This phase IV randomized controlled clinical trial intend to compare the effect of three close standard inhaled triple therapies and one close standard inhaled double therapy on the small airway in pa...
Detailed Description
Selection visit day -21 to -1: The diagnosis of COPD-B or BCNO will be verified. The inclusion criteria will be checked and it will be verified if there are any exclusion criteria (clinical record wil...
Eligibility Criteria
Inclusion
- Subject capable of understanding instructions and giving her consent for participation.
- Diagnosis of COPD or chronic bronchitis without obstruction due to biomass smoke exposure:
- Diagnosis of COPD according to GOLD guidelines 2023 with: \>100 hours-year of biomass exposure index, and with a post-bronchodilator spirometry FEV1 \> 70% of predicted value.
- Diagnosis of Chronic Bronchitis without obstruction with at least \>100 hours-year of biomass smoke exposure index or more than 10 years of continued exposure to biomass smoke, and with 1) antecedent of chronic bronchitis, and 2) post-bronchodilator spirometry FEV1/FVC \>0.7.
- Able to attend all visits.
- Cooperative patients with adequate understanding and skill in using inhalers, or with caregivers capable of administering medications and filling out a daily symptom diary.
- Stable patients, with no history of exacerbations in the last 4 weeks before inclusion.
Exclusion
- Pregnancy or in the breastfeeding period.
- Documented allergy or intolerance to any of the study medications.
- History of clinically significant bronchiectasis, tuberculosis, recent respiratory infection (4 weeks), or cardiovascular comorbidity that contraindicates pulmonary function tests or that influences their status and functional class.
- Patients with suspicion or history of cancer.
- Uncontrolled diseases: acute hyperthyroidism, acute uncontrolled DM2, acid-peptic disease that causes bleeding, uncontrolled hematological diseases, etc. In general, any decompensated disease that, in the opinion of the principal investigator, may influence the results of the study.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06571942
Start Date
November 15 2023
End Date
January 15 2025
Last Update
August 26 2024
Active Locations (1)
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1
Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"
Mexico City, Tlalpan, Mexico, 14080