Actively Recruiting
Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Led by National Institute of Respiratory Diseases, Mexico · Updated on 2024-08-26
128
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 patients with Chronic Obstructive Pulmonary Disease (COPD-B) and chronic bronchitis without obstruction (BCNO) exposed to wood smoke. The treatment phase duration is of 3 months. As primary outcome, the resistance change in post-bronchodilatator impulse oscilometry will me measure at 30 minutes, 2 hours, 4 hours, and 24 hours post first dose of the asigned medication, and then at 1 and 3 months of treatment. As secondary outcomes, change in respiratory symptoms and health related quality of life will be assess after 1 and 3 months of treatment.
CONDITIONS
Official Title
Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand instructions and provide consent for participation
- Diagnosis of COPD or chronic bronchitis without obstruction due to biomass smoke exposure
- COPD diagnosis per GOLD 2023 with >100 hours-year biomass exposure and post-bronchodilator FEV1 > 70% predicted
- Chronic bronchitis without obstruction with >100 hours-year biomass exposure or >10 years continuous exposure, with chronic bronchitis history and post-bronchodilator FEV1/FVC > 0.7
- Able to attend all visits
- Cooperative with inhaler use or with caregiver able to administer medication and complete symptom diary
- Stable condition with no exacerbations in past 4 weeks before inclusion
You will not qualify if you...
- Pregnant or breastfeeding
- Allergy or intolerance to any study medication
- History of significant bronchiectasis, tuberculosis, recent respiratory infection (within 4 weeks), or cardiovascular conditions that affect lung tests or functional status
- Suspicion or history of cancer
- Uncontrolled diseases such as acute hyperthyroidism, uncontrolled diabetes, bleeding acid-peptic disease, uncontrolled blood disorders, or any decompensated disease that may affect study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"
Mexico City, Tlalpan, Mexico, 14080
Actively Recruiting
Research Team
A
Alejandra Ramírez-Venegas, MCs
CONTACT
R
Rogelio Pérez-Padilla, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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