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

Thammasat University22 enrolled

Overview

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?

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COPD Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Budesonide/Glycopyrronium/Formoterol (BGF)DRUG

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

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.