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

Phase 4

Recruiting

• Conditions: COPD; Chronic Obstructive Pulmonary Disease (COPD); Triple Therapy; Small Airway Disease; Lung Function
• Interventions: Drug: Budesonide/Glycopyrronium/Formoterol (BGF); Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)

• Registration Number: NCT06905483
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Budesonide/Glycopyrronium/Formoterol (BGF)	Budesonide/Glycopyrronium/Formoterol (BGF)	BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks
Budesonide/Glycopyrronium/Formoterol (BGF)	Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)	BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks
Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)	Budesonide/Glycopyrronium/Formoterol (BGF)	FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks
Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)	Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)	FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Changes in airway resistance at 5 Hz (R5) on COPD patients	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	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	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	From enrollment to the end of treatment at 8 weeks	Changes in X5 assessed by impulse oscillometry (IOS), reported as kPa/L/s.

Secondary Outcome Measures

Name	Time	Method
Changes in forced expiratory volume in 1 second (FEV1) in COPD patients	From enrollment to the end of treatment at 8 weeks	Changes in FEV1 assessed by spirometry, reported as liter (L) and percent predicted value.
Changes in forced vital capacity (FVC) in COPD patients	From enrollment to the end of treatment at 8 weeks	Changes in FVC assessed by spirometry, reported as liter (L) and percent predicted value.
Changes in FEV1/FVC ratio in COPD patients	From enrollment to the end of treatment at 8 weeks	Changes in FEV1/FVC ratio assessed by spirometry, reported as percent.
Changes in forced expiratory flow at 25-75% of FVC (FEF25-75) in COPD patients	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.
Changes in modified Medical Research Council dyspnea scale in COPD patients	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.
Changes in COPD assessment test score in COPD patients	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.

Trial Locations

Locations (1)

Narongkorn Saiphoklang; 🇹🇭 Pathumthani, Thailand