Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
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
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in airway resistance at 5 Hz (R5) on COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Changes in airway resistance at 20 Hz (R20) on COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 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
measure: Reactance at 5 Hz (X5) on COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Changes in forced expiratory volume in 1 second (FEV1) in COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Changes in forced vital capacity (FVC) in COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Changes in FEV1/FVC ratio in COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Changes in forced expiratory flow at 25-75% of FVC (FEF25-75) in COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Changes in modified Medical Research Council dyspnea scale in COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Changes in COPD assessment test score in COPD patients
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Narongkorn Saiphoklang
Study officials:
affiliation: Thammasat University Faculty of Medicine
name: Narongkorn Saiphoklang, MD
role: PRINCIPAL_INVESTIGATOR
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