NCT06571942 Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
| NCT ID | NCT06571942 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Institute of Respiratory Diseases, Mexico |
| Condition | COPD Bronchitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2025-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 128 participants in total. It began in 2023-11-15 with a primary completion date of 2025-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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: 1. 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. 2. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06571942 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 85 Years, studying COPD Bronchitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06571942 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06571942 currently recruiting?
Yes, NCT06571942 is actively recruiting participants. Contact the research team at aleravas@hotmail.com for enrollment information.
Where is the NCT06571942 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06571942 clinical trial?
NCT06571942 is sponsored by National Institute of Respiratory Diseases, Mexico. The trial plans to enroll 128 participants.
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