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

NCT06571942 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-08-26

No results posted yet for this study

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.

Conditions

  • COPD Bronchitis
  • Pollution Related Respiratory Disorder

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

Sponsors & Collaborators

  • National Institute of Respiratory Diseases, Mexico

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2025-01-15
Completion
2025-01-15
FDA Drug
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571942 on ClinicalTrials.gov