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

NCT06571942 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: C74-23
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Biomass; COPD; Chronic bronchitis; Inhaled therapy

Outcome Measures

Primary Outcomes (1)

• Change in impulse oscillometry

  To quantify the change in impulse oscillometry (post-bronchodilator) change in total resistance measured in percentage change from baseline change R5-R20 and/or AX for the patients who used Vilanterol / Umeclidinium 25/62.5 mcg once daily = ANORO®; Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily= TRELEGY®; Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily = TRIMBOW®; and Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg two inhalations twice daily= TRIXEO®.

  3 months

Secondary Outcomes (12)

• Change of resistences in impulse oscillometry

  30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months

• Change of resistences in impulse oscillometry

  30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months

• Change of total resistances in pletismography

  30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months

• Chance in lung function in spirometry

  30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months

• Chance in lung function in spirometry

  30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months

Study Arms (2)

COPD due to biomass exposure

EXPERIMENTAL

Vilanterol / Umeclidinium 25/62.5 mcg once daily for three months = ANORO® Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily for three months = TRELEGY® Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily for three months = TRIMBOW® Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg; two inhalations twice daily for three months= TRIXEO®

Drug: Vilanterol / Umeclidinium (25/62.5 mcg); Drug: Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg); Drug: Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; Drug: Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg

Chronic bronchitis without obstruction due to biomass exposure

EXPERIMENTAL

Vilanterol / Umeclidinium 25/62.5 mcg once daily for three months = ANORO® Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily for three months = TRELEGY® Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily for three months = TRIMBOW® Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg; two inhalations twice daily for three months= TRIXEO®

Drug: Vilanterol / Umeclidinium (25/62.5 mcg); Drug: Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg); Drug: Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; Drug: Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg

Interventions

Vilanterol / Umeclidinium (25/62.5 mcg) DRUG

One inhalation daily from Ellipta device for three months

Also known as: ANORO

COPD due to biomass exposure; Chronic bronchitis without obstruction due to biomass exposure

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

One inhalation daily from Ellipta device for three months

Also known as: TRELEGY

COPD due to biomass exposure; Chronic bronchitis without obstruction due to biomass exposure

Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg DRUG

Two inhalations twice daily form pMDI device for three months

Also known as: TRIMBOW

COPD due to biomass exposure; Chronic bronchitis without obstruction due to biomass exposure

Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg DRUG

Two inhalations twice daily form pMDI device for three months

Also known as: TRIXEO

COPD due to biomass exposure; Chronic bronchitis without obstruction due to biomass exposure

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject capable of understanding instructions and giving her consent for participation.
• Diagnosis of COPD or chronic bronchitis without obstruction due to biomass smoke exposure:
• Diagnosis of COPD according to GOLD guidelines 2023 with: \>100 hours-year of biomass exposure index, and with a post-bronchodilator spirometry FEV1 \> 70% of predicted value.
• Diagnosis of Chronic Bronchitis without obstruction with at least \>100 hours-year of biomass smoke exposure index or more than 10 years of continued exposure to biomass smoke, and with 1) antecedent of chronic bronchitis, and 2) post-bronchodilator spirometry FEV1/FVC \>0.7.
• Able to attend all visits.
• Cooperative patients with adequate understanding and skill in using inhalers, or with caregivers capable of administering medications and filling out a daily symptom diary.

You may not qualify if:

• Pregnancy or in the breastfeeding period.
• Documented allergy or intolerance to any of the study medications.
• History of clinically significant bronchiectasis, tuberculosis, recent respiratory infection (4 weeks), or cardiovascular comorbidity that contraindicates pulmonary function tests or that influences their status and functional class.
• Patients with suspicion or history of cancer.
• Uncontrolled diseases: acute hyperthyroidism, acute uncontrolled DM2, acid-peptic disease that causes bleeding, uncontrolled hematological diseases, etc. In general, any decompensated disease that, in the opinion of the principal investigator, may influence the results of the study.

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

Insituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas"

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

vilanterol; GSK573719; Beclomethasone; Formoterol Fumarate; Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes

Central Study Contacts

Alejandra Ramírez-Venegas, MCs

CONTACT

+52 55 54 87 17 00; aleravas@hotmail.com

Rogelio Pérez-Padilla, Dr

CONTACT

+52 55 54 87 17 00

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Study comparing the effect of 3 inhaled triple therapies and 1 inhaled double therapy in small airway in COPD and pre-COPD patients for three months

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: August 26, 2024
• Study Start: November 15, 2023
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD data will be available for sharing after the results are published. The data will me available for one year.
• Access Criteria: The information may be requested by researchers who wish to carry out a meta-analysis. The main author will evaluate the applications for sharing the data.

Locations

ME (1)