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

January 29, 2026 updated by: Narongkorn Saiphoklang, MD, Thammasat University

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Changwat Pathum Thani
      • Pathum Thani, Changwat Pathum Thani, Thailand, 12120
        • Narongkorn Saiphoklang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide/Glycopyrronium/Formoterol (BGF)
BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks
Drug: Budesonide/Glycopyrronium/Formoterol (BGF)
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
Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
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
Active Comparator: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks
Drug: Budesonide/Glycopyrronium/Formoterol (BGF)
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
Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Narongkorn Saiphoklang, MD, Thammasat University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 28, 2026

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-IM-5-271/67

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD and documents will be available for sharing immediately after publication for a period of 2 years.

IPD Sharing Time Frame

IPD and documents will be available for sharing immediately after publication for a period of 2 years.

IPD Sharing Access Criteria

All researchers will be able to access the IPD and supporting information via the repository website without restriction.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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