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NCT06571942 · ClinicalTrials.gov record · last posted 2024-08-26

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

StatusRecruiting
PhasePhase 4
Started2023-11-15
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 26, 2024 (before its estimated January 15, 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT06571942
Lead Sponsor National Institute of Respiratory Diseases, Mexico
Conditions COPD Bronchitis, Pollution Related Respiratory Disorder
Enrollment 128 participants
Start Date 2023-11-15
Primary Completion 2025-01-15 (estimated)
Study Completion 2025-01-15 (estimated)
Updated on ClinicalTrials.gov 2024-08-26