Chronic Obstructive Pulmonary Disease (COPD), COPD, Lung Function, Small Airway Disease, Triple Therapy
Conditions
Keywords
COPD, chronic obstructive pulmonary disease, small airway disease, triple inhaled therapy, Budesonide/Glycopyrronium/Formoterol, Fluticasone Furoate/Umeclidinium/Vilanterol
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.
Interventions
DRUGBudesonide/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.
DRUGFluticasone 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
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORNarongkorn Saiphoklang, MD
Thammasat University Faculty of Medicine
Outcome results
None listed