RecruitingPhase 4NCT06571942

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


Sponsor

National Institute of Respiratory Diseases, Mexico

Enrollment

128 participants

Start Date

Nov 15, 2023

Study Type

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

Sex: FEMALEMin Age: 35 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how inhaled combination inhalers (triple therapy) affect the small airways in people with lung disease caused by breathing in smoke from burning wood or other biomass fuels — common in some communities that cook or heat with open fires. **You may be eligible if...** - You have COPD or chronic bronchitis caused by significant biomass smoke exposure (e.g., cooking fires) - You are able to use an inhaler correctly, or have a caregiver who can help - You are able to attend all study visits - You understand the instructions and are willing to give consent **You may NOT be eligible if...** - You are unable to attend study visits - You cannot use or be taught to use inhalers properly - You do not meet the medical criteria for COPD or chronic bronchitis from biomass exposure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVilanterol / Umeclidinium (25/62.5 mcg)

One inhalation daily from Ellipta device for three months

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

One inhalation daily from Ellipta device for three months

DRUGBeclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg

Two inhalations twice daily form pMDI device for three months

DRUGBudesonide / 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

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NCT06571942


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