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RECRUITING
NCT06571942
PHASE4

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

Sponsor: National Institute of Respiratory Diseases, Mexico

View on ClinicalTrials.gov

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

DRUG

Vilanterol / Umeclidinium (25/62.5 mcg)

One inhalation daily from Ellipta device for three months

DRUG

Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg)

One inhalation daily from Ellipta device for three months

DRUG

Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg

Two inhalations twice daily form pMDI device for three months

DRUG

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