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 University

Status and phase: Completed; Phase 4

Conditions: Triple Therapy; Lung Function; Small Airway Disease; COPD; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV); Drug: Budesonide/Glycopyrronium/Formoterol (BGF)

Study type: Interventional

Funder types: Other

Identifiers

NCT06905483

MTU-EC-IM-5-271/67

Details and patient eligibility

About

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?

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Budesonide/Glycopyrronium/Formoterol (BGF)

Experimental group

Description:

BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks

Treatment:

Drug: Budesonide/Glycopyrronium/Formoterol (BGF)

Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)

Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)

Active Comparator group

Description:

FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks

Treatment:

Drug: Budesonide/Glycopyrronium/Formoterol (BGF)

Drug: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)