Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure

Phase 4

Recruiting

• Conditions: COPD Bronchitis; Pollution Related Respiratory Disorder

• Registration Number: NCT06571942
• Lead Sponsor: National Institute of Respiratory Diseases, Mexico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

Inclusion Criteria:<br><br> - Subject capable of understanding instructions and giving her consent for<br> participation.<br><br> - Diagnosis of COPD or chronic bronchitis without obstruction due to biomass smoke<br> exposure:<br><br> 1. Diagnosis of COPD according to GOLD guidelines 2023 with: >100 hours-year of<br> biomass exposure index, and with a post-bronchodilator spirometry FEV1 > 70% of<br> predicted value.<br><br> 2. Diagnosis of Chronic Bronchitis without obstruction with at least >100<br> hours-year of biomass smoke exposure index or more than 10 years of continued<br> exposure to biomass smoke, and with 1) antecedent of chronic bronchitis, and 2)<br> post-bronchodilator spirometry FEV1/FVC >0.7.<br><br> - Able to attend all visits.<br><br> - Cooperative patients with adequate understanding and skill in using inhalers, or<br> with caregivers capable of administering medications and filling out a daily symptom<br> diary.<br><br> - Stable patients, with no history of exacerbations in the last 4 weeks before<br> inclusion.<br><br>Exclusion Criteria:<br><br> - Pregnancy or in the breastfeeding period.<br><br> - Documented allergy or intolerance to any of the study medications.<br><br> - History of clinically significant bronchiectasis, tuberculosis, recent respiratory<br> infection (4 weeks), or cardiovascular comorbidity that contraindicates pulmonary<br> function tests or that influences their status and functional class.<br><br> - Patients with suspicion or history of cancer.<br><br> - Uncontrolled diseases: acute hyperthyroidism, acute uncontrolled DM2, acid-peptic<br> disease that causes bleeding, uncontrolled hematological diseases, etc. In general,<br> any decompensated disease that, in the opinion of the principal investigator, may<br> influence the results of the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in impulse oscillometry

Secondary Outcome Measures

Name	Time	Method
Change of resistences in impulse oscillometry;Change of resistences in impulse oscillometry;Change of total resistances in pletismography;Chance in lung function in spirometry;Chance in lung function in spirometry;Chance in FEF25-75 in spirometry;Chance in MMEF(L/s) in spirometry;Adherence assesment;Change in Fractional exhaled nitric oxide;Change in Chronic Obstructive Pulmonary Disease Assesment Test;Change in Saint George Respiratory Questionnaire;Change in dypsnea by modified Medical Research Council score