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Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Sponsor: National Institute of Respiratory Diseases, 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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
35 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2023-11-15
Completion Date
2025-01-15
Last Updated
2024-08-26
Healthy Volunteers
No
Interventions
Vilanterol / Umeclidinium (25/62.5 mcg)
One inhalation daily from Ellipta device for three months
Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg)
One inhalation daily from Ellipta device for three months
Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg
Two inhalations twice daily form pMDI device for three months
Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg
Two inhalations twice daily form pMDI device for three months
Locations (1)
Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"
Mexico City, Tlalpan, Mexico