Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Recruiting · NCT06571942 · Interventional (participants receive a specific treatment) · Lead sponsor: National Institute of Respiratory Diseases, Mexico
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas" - Mexico City, Tlalpan, Mexico