Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
NCT Number: NCT06571942
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: COPD Bronchitis|Pollution Related Respiratory Disorder
Interventions: DRUG: Vilanterol / Umeclidinium (25/62.5 mcg)|DRUG: Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg)|DRUG: Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg|DRUG: Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg
Sponsor: National Institute of Respiratory Diseases, Mexico
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-15
Completion Date: 2025-01-15
Locations: Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas", Ciudad de México, Tlalpan, 14080, Mexico

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.

Primary Outcome Measures: Change in impulse oscillometry, To quantify the change in impulse oscillometry (post-bronchodilator) change in total resistance measured in percentage change from baseline change R5-R20 and/or AX for the patients who used Vilanterol / Umeclidinium 25/62.5 mcg once daily = ANORO®; Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily= TRELEGY®; Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily = TRIMBOW®; and Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg two inhalations twice daily= TRIXEO®., 3 months
Secondary Outcome Measures: Change of resistences in impulse oscillometry, Quantify the change in R5, R20, R5-R20 \[kPa/(L/s)\], 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months|Change of resistences in impulse oscillometry, Quantify the change in Ax \[kPa/L\], 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months|Change of total resistances in pletismography, Change in total resistances (kPa\*s/L), measured by plethysmography., 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months|Chance in lung function in spirometry, Change in FEV1, and FVC, both in liters., 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months|Chance in lung function in spirometry, Change in FEV1, and FVC, both percentage of predicted, 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months|Chance in FEF25-75 in spirometry, Change in FEF25-75 (L/s), 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months|Chance in MMEF(L/s) in spirometry, Change in MMEF(L/s), 30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months|Adherence assesment, Quantify adherence to treatment according to the type of inhaler., 3 months|Change in Fractional exhaled nitric oxide, Change in exhaled fraction of nitric oxide measured by parts per billion., 3 months|Change in Chronic Obstructive Pulmonary Disease Assesment Test, Change in quality of life in Chronic Obstructive Pulmonary Disease Assesment Test score, 3 months|Change in Saint George Respiratory Questionnaire, Change in quality of life in the Saint George respiratory questionnaire scores, 3 months|Change in dypsnea by modified Medical Research Council score, Change in dyspnea score measured by the modified Medical Research Council test, 3 months