CompletedPhase 4

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

Thailand22 participantsStarted 2025-04-01

Plain-language 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?

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From enrollment to the end of treatment at 8 weeks

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

Timeframe: 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

Timeframe: From enrollment to the end of treatment at 8 weeks

Reactance at 5 Hz (X5) on COPD patients

Timeframe: From enrollment to the end of treatment at 8 weeks

Trial details

NCT IDNCT06905483

SponsorThammasat University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More COPD trials

Plain-language summary

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: From enrollment to the end of treatment at 8 weeks

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

Timeframe: 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

Timeframe: From enrollment to the end of treatment at 8 weeks

Reactance at 5 Hz (X5) on COPD patients

Timeframe: From enrollment to the end of treatment at 8 weeks