Comparing inhaled therapies for COPD and chronic bronchitis from biomass exposure
Effect of the Inhaled Triple Therapies Over the Small Airway in Patients With Chronic Obstructive Pulmonary Disease or Chronic Bronchitis Without Obstruction Secondary to Biomass Exposure: Randomized Controlled Clinical Trial Phase IV
This study is testing if different inhaled treatments can help people with COPD and chronic bronchitis, who have been exposed to wood smoke, breathe better and improve their quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | Female |
| Sponsor | National Institute of Respiratory Diseases, Mexico Government |
| Locations | 1 site (Mexico City, Tlalpan) |
| Trial ID | NCT06571942 on ClinicalTrials.gov |
What this trial studies
This phase IV randomized controlled trial aims to evaluate the effects of three inhaled triple therapies and one inhaled double therapy on small airway resistance in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis without obstruction, specifically those exposed to wood smoke. The study will measure changes in airway resistance using impulse oscillometry at various time points after treatment initiation, alongside assessing respiratory symptoms and quality of life over a three-month treatment period. Patients will undergo a thorough screening process to confirm eligibility based on specific diagnostic criteria and will be monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with COPD or chronic bronchitis without obstruction due to biomass smoke exposure, who have stable conditions and can attend all study visits.
Not a fit: Patients with recent exacerbations, those unable to use inhalers effectively, or those with certain exclusion criteria such as pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from COPD and chronic bronchitis related to biomass smoke exposure.
How similar studies have performed: Other studies have shown promising results with inhaled therapies for COPD, suggesting that this approach may be beneficial, although this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City, Tlalpan
- Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas" — Mexico City, Tlalpan, Mexico (Recruiting)
Study contacts
- Study coordinator: Alejandra Ramírez-Venegas, MCs
- Email: aleravas@hotmail.com
- Phone: +52 55 54 87 17 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.