COPDPhase 4NCT06905483
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
A Phase 4 study testing Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) in people with COPD and Chronic Obstructive Pulmonary Disease (COPD), run by Thammasat University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease
- What is being tested?
- Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2025to 28 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC < 70%)
- Aged 40-80 years
- Smoking 10 pack-years or more
- Postbronchodilator FEV1 < 80%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Narongkorn Saiphoklang
Pathum Thani, Changwat Pathum Thani, 12120
About this 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?
Read the 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.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease, Triple Therapy, Lung Function
- Being tested
- Budesonide/Glycopyrronium/Formoterol (BGF), Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
- Keywords
- COPD, chronic obstructive pulmonary disease, small airway disease, triple inhaled therapy, Budesonide/Glycopyrronium/Formoterol, Fluticasone Furoate/Umeclidinium/Vilanterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/Glycopyrronium/Formoterol (BGF)Drug
Also called Breztri
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.
Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)Drug
Also called Trelegy
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.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide/Glycopyrronium/Formoterol (BGF) | Experimental | BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks Receives: Drug: Budesonide/Glycopyrronium/Formoterol (BGF); Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) | Active comparator | FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks Receives: Drug: Budesonide/Glycopyrronium/Formoterol (BGF); Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in airway resistance at 5 Hz (R5) on COPD patients
Changes in R5 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value.
Measured: From enrollment to the end of treatment at 8 weeks
Changes in airway resistance at 20 Hz (R20) on COPD patients
Changes in R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value.
Measured: 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
Changes in R5-R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s.
Measured: From enrollment to the end of treatment at 8 weeks
Reactance at 5 Hz (X5) on COPD patients
Changes in X5 assessed by impulse oscillometry (IOS), reported as kPa/L/s.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Changes in forced expiratory volume in 1 second (FEV1) in COPD patients
Changes in FEV1 assessed by spirometry, reported as liter (L) and percent predicted value.
Measured: From enrollment to the end of treatment at 8 weeks
Changes in forced vital capacity (FVC) in COPD patients
Changes in FVC assessed by spirometry, reported as liter (L) and percent predicted value.
Measured: From enrollment to the end of treatment at 8 weeks
Changes in FEV1/FVC ratio in COPD patients
Changes in FEV1/FVC ratio assessed by spirometry, reported as percent.
Measured: 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
Changes in FEF25-75 assessed by spirometry, reported as liter/second (L/s) and percent predicted value.
Measured: From enrollment to the end of treatment at 8 weeks
Changes in modified Medical Research Council dyspnea scale in COPD patients
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.
Measured: From enrollment to the end of treatment at 8 weeks
Changes in COPD assessment test score in COPD patients
Changes in this score are reported in points, with a minimum range of 0 and a maximum of 40. Higher scores indicate more symptoms.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025
- Primary completion31 Dec 2025
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model 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, pulmonary function, and safety are assessed.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongkorn Saiphoklang, MD, Thammasat University
- Investigators
- Narongkorn Saiphoklang, MD, Principal investigator, Thammasat University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905483
- Sponsor's protocol ID
- MTU-EC-IM-5-271/67
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD and documents will be available for sharing immediately after publication for a period of 2 years.
Publications
Usmani O, Li G, De Backer J, Sadafi H, Wu L, Marshall J. Modeled small airways lung deposition of two fixed-dose triple therapy combinations assessed with in silico functional respiratory imaging. Respir Res. 2023 Sep 23;24(1):226. doi: 10.1186/s12931-023-02534-y.
PubMed 37742015Usmani OS, Scichilone N, Mignot B, Belmans D, Van Holsbeke C, De Backer J, De Maria R, Cuoghi E, Topole E, Georges G. Airway Deposition of Extrafine Inhaled Triple Therapy in Patients with COPD: A Model Approach Based on Functional Respiratory Imaging Computer Simulations. Int J Chron Obstruct Pulmon Dis. 2020 Oct 7;15:2433-2440. doi: 10.2147/COPD.S269001. eCollection 2020.
PubMed 33116458Bremner PR, Birk R, Brealey N, Ismaila AS, Zhu CQ, Lipson DA. Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study. Respir Res. 2018 Jan 25;19(1):19. doi: 10.1186/s12931-018-0724-0.
PubMed 29370819Bansal S, Anderson M, Anzueto A, Brown N, Compton C, Corbridge TC, Erb D, Harvey C, Kaisermann MC, Kaye M, Lipson DA, Martin N, Zhu CQ, Papi A. Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD. NPJ Prim Care Respir Med. 2021 May 25;31(1):29. doi: 10.1038/s41533-021-00241-z.
PubMed 34035312Lipson DA, Barnacle H, Birk R, Brealey N, Locantore N, Lomas DA, Ludwig-Sengpiel A, Mohindra R, Tabberer M, Zhu CQ, Pascoe SJ. FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446. doi: 10.1164/rccm.201703-0449OC.
PubMed 28375647Maneechotesuwan K, Sawatdee S, Srichana T. In Vitro Analysis of Aerodynamic Properties and Co-Deposition of a Fixed-Dose Combination of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate. Pharmaceutics. 2024 Oct 18;16(10):1334. doi: 10.3390/pharmaceutics16101334.
PubMed 39458663Martinez FJ, Rabe KF, Ferguson GT, Wedzicha JA, Trivedi R, Jenkins M, Darken P, Aurivillius M, Dorinsky P. Benefits of budesonide/glycopyrrolate/formoterol fumarate (BGF) on symptoms and quality of life in patients with COPD in the ETHOS trial. Respir Med. 2021 Aug-Sep;185:106509. doi: 10.1016/j.rmed.2021.106509. Epub 2021 Jun 18.
PubMed 34171789Ishiura Y, Fujimura M, Ohkura N, Hara J, Kasahara K, Ishii N, Sawai Y, Shimizu T, Tamaki T, Nomura S. Triple Therapy with Budesonide/Glycopyrrolate/Formoterol Fumarate Improves Inspiratory Capacity in Patients with Asthma-Chronic Obstructive Pulmonary Disease Overlap. Int J Chron Obstruct Pulmon Dis. 2020 Feb 5;15:269-277. doi: 10.2147/COPD.S231004. eCollection 2020.
PubMed 32103926Rabe KF, Martinez FJ, Singh D, Trivedi R, Jenkins M, Darken P, Aurivillius M, Dorinsky P. Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trial. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211034329. doi: 10.1177/17534666211034329.
PubMed 34428980Ferguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, Bourne E, Ballal S, Darken P, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):747-758. doi: 10.1016/S2213-2600(18)30327-8. Epub 2018 Sep 16.
PubMed 30232048Usmani O, Roche N, Wahab E, Israel S, Jenkins M, Trivedi R, Dorinsky P, Aurivillius M. A scintigraphy study of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2021 Oct 7;22(1):261. doi: 10.1186/s12931-021-01813-w.
PubMed 34620167Bickel S, Popler J, Lesnick B, Eid N. Impulse oscillometry: interpretation and practical applications. Chest. 2014 Sep;146(3):841-847. doi: 10.1378/chest.13-1875.
PubMed 25180727McNulty W, Usmani OS. Techniques of assessing small airways dysfunction. Eur Clin Respir J. 2014 Oct 17;1. doi: 10.3402/ecrj.v1.25898. eCollection 2014.
PubMed 26557240Lazarinis N, Fouka E, Linden A, Bossios A. Small airways disease in chronic obstructive pulmonary disease. Expert Rev Respir Med. 2024 Jul;18(7):539-552. doi: 10.1080/17476348.2024.2380070. Epub 2024 Jul 24.
PubMed 39046133Singh D, Long G, Cancado JED, Higham A. Small airway disease in chronic obstructive pulmonary disease: insights and implications for the clinician. Curr Opin Pulm Med. 2020 Mar;26(2):162-168. doi: 10.1097/MCP.0000000000000637.
PubMed 31688242
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06905483
- Acronym / sponsor ID
- MTU-EC-IM-5-271/67
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease, Triple Therapy, Lung Function
- Keywords
- COPD, chronic obstructive pulmonary disease, small airway disease, triple inhaled therapy, Budesonide/Glycopyrronium/Formoterol, Fluticasone Furoate/Umeclidinium/Vilanterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model 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, pulmonary function, and safety are assessed.
| Arm | Type | Receives |
|---|---|---|
| Budesonide/Glycopyrronium/Formoterol (BGF) | Experimental | Drug: Budesonide/Glycopyrronium/Formoterol (BGF), Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) | Active comparator | Drug: Budesonide/Glycopyrronium/Formoterol (BGF), Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC < 70%)
- Aged 40-80 years
- Smoking 10 pack-years or more
- Postbronchodilator FEV1 < 80%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/Glycopyrronium/Formoterol (BGF)Also: BreztriEach 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. | Drug | Budesonide/Glycopyrronium/Formoterol (BGF), Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) |
| Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)Also: TrelegyEach 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. | Drug | Budesonide/Glycopyrronium/Formoterol (BGF), Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
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 forced vital capacity (FVC) in COPD patients
Time frame: 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 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 modified Medical Research Council dyspnea scale in COPD patients
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 37742015Usmani O, Li G, De Backer J, Sadafi H, Wu L, Marshall J. Modeled small airways lung deposition of two fixed-dose triple therapy combinations assessed with in silico functional respiratory imaging. Respir Res. 2023 Sep 23;24(1):226. doi: 10.1186/s12931-023-02534-y.
- Results publication: PubMed 33116458Usmani OS, Scichilone N, Mignot B, Belmans D, Van Holsbeke C, De Backer J, De Maria R, Cuoghi E, Topole E, Georges G. Airway Deposition of Extrafine Inhaled Triple Therapy in Patients with COPD: A Model Approach Based on Functional Respiratory Imaging Computer Simulations. Int J Chron Obstruct Pulmon Dis. 2020 Oct 7;15:2433-2440. doi: 10.2147/COPD.S269001. eCollection 2020.
- Results publication: PubMed 29370819Bremner PR, Birk R, Brealey N, Ismaila AS, Zhu CQ, Lipson DA. Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study. Respir Res. 2018 Jan 25;19(1):19. doi: 10.1186/s12931-018-0724-0.
- Results publication: PubMed 34035312Bansal S, Anderson M, Anzueto A, Brown N, Compton C, Corbridge TC, Erb D, Harvey C, Kaisermann MC, Kaye M, Lipson DA, Martin N, Zhu CQ, Papi A. Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD. NPJ Prim Care Respir Med. 2021 May 25;31(1):29. doi: 10.1038/s41533-021-00241-z.
- Results publication: PubMed 28375647Lipson DA, Barnacle H, Birk R, Brealey N, Locantore N, Lomas DA, Ludwig-Sengpiel A, Mohindra R, Tabberer M, Zhu CQ, Pascoe SJ. FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446. doi: 10.1164/rccm.201703-0449OC.
- Results publication: PubMed 39458663Maneechotesuwan K, Sawatdee S, Srichana T. In Vitro Analysis of Aerodynamic Properties and Co-Deposition of a Fixed-Dose Combination of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate. Pharmaceutics. 2024 Oct 18;16(10):1334. doi: 10.3390/pharmaceutics16101334.
- Results publication: PubMed 34171789Martinez FJ, Rabe KF, Ferguson GT, Wedzicha JA, Trivedi R, Jenkins M, Darken P, Aurivillius M, Dorinsky P. Benefits of budesonide/glycopyrrolate/formoterol fumarate (BGF) on symptoms and quality of life in patients with COPD in the ETHOS trial. Respir Med. 2021 Aug-Sep;185:106509. doi: 10.1016/j.rmed.2021.106509. Epub 2021 Jun 18.
- Results publication: PubMed 32103926Ishiura Y, Fujimura M, Ohkura N, Hara J, Kasahara K, Ishii N, Sawai Y, Shimizu T, Tamaki T, Nomura S. Triple Therapy with Budesonide/Glycopyrrolate/Formoterol Fumarate Improves Inspiratory Capacity in Patients with Asthma-Chronic Obstructive Pulmonary Disease Overlap. Int J Chron Obstruct Pulmon Dis. 2020 Feb 5;15:269-277. doi: 10.2147/COPD.S231004. eCollection 2020.
- Results publication: PubMed 34428980Rabe KF, Martinez FJ, Singh D, Trivedi R, Jenkins M, Darken P, Aurivillius M, Dorinsky P. Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trial. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211034329. doi: 10.1177/17534666211034329.
- Results publication: PubMed 30232048Ferguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, Bourne E, Ballal S, Darken P, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):747-758. doi: 10.1016/S2213-2600(18)30327-8. Epub 2018 Sep 16.
- Results publication: PubMed 34620167Usmani O, Roche N, Wahab E, Israel S, Jenkins M, Trivedi R, Dorinsky P, Aurivillius M. A scintigraphy study of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2021 Oct 7;22(1):261. doi: 10.1186/s12931-021-01813-w.
- Results publication: PubMed 25180727Bickel S, Popler J, Lesnick B, Eid N. Impulse oscillometry: interpretation and practical applications. Chest. 2014 Sep;146(3):841-847. doi: 10.1378/chest.13-1875.
- Individual participant dataSharing planned: Yes. IPD and documents will be available for sharing immediately after publication for a period of 2 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narongkorn Saiphoklang, MD principal investigator
Thammasat University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) in people with COPD and Chronic Obstructive Pulmonary Disease (COPD), run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in airway resistance at 5 Hz (R5) on COPD patients (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905483, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.