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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes in airway resistance at 5 Hz (R5) on COPD patients
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC < 70%)
- •Aged 40-80 years
- •Smoking 10 pack-years or more
- •Postbronchodilator FEV1 < 80%
排除标准
- •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
研究组 & 干预措施
Budesonide/Glycopyrronium/Formoterol (BGF)
BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks
干预措施: Budesonide/Glycopyrronium/Formoterol (BGF) (Drug)
Budesonide/Glycopyrronium/Formoterol (BGF)
BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks
干预措施: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) (Drug)
Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks
干预措施: Budesonide/Glycopyrronium/Formoterol (BGF) (Drug)
Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
FUV (100/62.5/25 mcg) 1 inhalation, once daily for 4 weeks
干预措施: Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) (Drug)
结局指标
主要结局
Changes in airway resistance at 5 Hz (R5) on COPD patients
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From enrollment to the end of treatment at 8 weeks
Changes in X5 assessed by impulse oscillometry (IOS), reported as kPa/L/s.
次要结局
- Changes in forced expiratory volume in 1 second (FEV1) in COPD patients(From enrollment to the end of treatment at 8 weeks)
- Changes in forced vital capacity (FVC) in COPD patients(From enrollment to the end of treatment at 8 weeks)
- Changes in FEV1/FVC ratio in COPD patients(From enrollment to the end of treatment at 8 weeks)
- 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 modified Medical Research Council dyspnea scale in COPD patients(From enrollment to the end of treatment at 8 weeks)
- Changes in COPD assessment test score in COPD patients(From enrollment to the end of treatment at 8 weeks)
研究者
Narongkorn Saiphoklang, MD
Associate Professor
Thammasat University