Effect of the Inhaled Triple Therapies Over the Small Airway in 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
National Institute of Respiratory Diseases, Mexico
128 participants
Nov 15, 2023
INTERVENTIONAL
Conditions
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
Plain Language Summary
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Interventions
One inhalation daily from Ellipta device for three months
One inhalation daily from Ellipta device for three months
Two inhalations twice daily form pMDI device for three months
Two inhalations twice daily form pMDI device for three months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06571942