Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study

Last updated: April 25, 2025
Sponsor: Thammasat University
Overall Status: Active - Recruiting

Phase

4

Condition

Emphysema

Lung Disease

Chronic Obstructive Lung Disease

Treatment

Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)

Budesonide/Glycopyrronium/Formoterol (BGF)

Clinical Study ID

NCT06905483
MTU-EC-IM-5-271/67
  • Ages 40-80
  • All Genders

Study Summary

The goal of this clinical trial is to determine if triple inhaled therapy with Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.

The main questions it aims to answer are:

  • Does BGF demonstrate a comparable effect to FUV in COPD participants?

  • What medical problems do participants experience when taking BGFand FUV?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC < 70%)

  • Aged 40-80 years

  • Smoking 10 pack-years or more

  • Postbronchodilator FEV1 < 80%

Exclusion

Exclusion Criteria:

  • History of COPD exacerbation within 3 months

  • Asthma, bronchiectasis, pulmonary fibrosis

  • Inability to perform spirometry, impulse oscillometry, or 6-minute walk test

  • Pregnant or breastfeeding women

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
Phase: 4
Study Start date:
April 01, 2025
Estimated Completion Date:
March 31, 2026

Study Description

This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease are included. Each patient receives four weeks of treatment with either BGF or FUV followed by a one-week washout period, and then four weeks of treatment with the other drug. Respiratory symptoms are assessed using modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary function is assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) are also collected. Impulse oscillometry (IOS) is also performed, with results reported as R5, R20, R5-R20, X5, Fres, and Ax.

Connect with a study center

  • Narongkorn Saiphoklang

    Pathumthani, 12120
    Thailand

    Active - Recruiting

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