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OpenTrials
Completed

NCT Number: NCT06905483

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

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?

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Narongkorn Saiphoklang

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Budesonide/Glycopyrronium/Formoterol (BGF)

Drug

Each patient received 4 weeks of treatment with either BGF or FUV followed by a 1-week washout period, and then 4 weeks of treatment with the other drug.

Other names: Breztri

Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)

Drug

Each patient received 4 weeks of treatment with either BGF or FUV followed by a 1-week washout period, and then 4 weeks of treatment with the other drug.

Other names: Trelegy

Primary outcomes

  1. Changes in airway resistance at 5 Hz (R5) on COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in R5 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value.

  2. Changes in airway resistance at 20 Hz (R20) on COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value.

  3. Difference of airway resistance between 5 Hz and 20 Hz (R5-R20) on COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in R5-R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s.

  4. Reactance at 5 Hz (X5) on COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in X5 assessed by impulse oscillometry (IOS), reported as kPa/L/s.

Secondary outcomes

  1. Changes in forced expiratory volume in 1 second (FEV1) in COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in FEV1 assessed by spirometry, reported as liter (L) and percent predicted value.

  2. Changes in forced vital capacity (FVC) in COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in FVC assessed by spirometry, reported as liter (L) and percent predicted value.

  3. Changes in FEV1/FVC ratio in COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in FEV1/FVC ratio assessed by spirometry, reported as percent.

  4. Changes in forced expiratory flow at 25-75% of FVC (FEF25-75) in COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in FEF25-75 assessed by spirometry, reported as liter/second (L/s) and percent predicted value.

  5. Changes in modified Medical Research Council dyspnea scale in COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in this dyspnea scale are reported in points, with a minimum range of 0 and a maximum of 5. Higher scores indicate more symptoms.

  6. Changes in COPD assessment test score in COPD patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in this score are reported in points, with a minimum range of 0 and a maximum of 40. Higher scores indicate more symptoms.

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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