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
NCT06905483 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-02-02
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?
Conditions
- COPD
- Chronic Obstructive Pulmonary Disease (COPD)
- Small Airway Disease
- Triple Therapy
- Lung Function
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Thammasat University
lead OTHER
Principal Investigators
-
Narongkorn Saiphoklang, MD · Thammasat University Faculty of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-01-28
Countries
- Thailand
Study Locations
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