Randomized Double-blind Placebo-controlled Crossover Study to Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function in COPD Patients.
试验速览
- 阶段
- 4 期
- 发起方
- KU Leuven
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Physiologically measured small airway function based on MBW variables (Scond and Sacin) and lung functional variables (N2-washout, studying the plateau of phase III and closing volume).
研究概览
简要总结
Inuvair® is a novel fixed combination product used in the treatment of asthma and under clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is able to target the whole bronchial tree, including the small airways and hence, is expected to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its action on the small airways is not directly demonstrated thus far. By way of contrast, dear evidence is present that treatment with bronchodilators alone does not beneficially alter small airway function. The study hypothesis states that the effects of inhaled corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis COPD according to last updated GOLD guidelines (post- bronchodilator FEV/FVC below 0,70, FEV1 <80% predicted)
- •ex-smokers (ie 1 year from the last cigarette) with at least 10 pack years.
- •GOLD stage II and III (FEV1 > 30% predicted)
- •by preference naïve to inhaled corticosteroids; in those taking inhaled corticosteroids this medication will be stopped 1 month prior to enrollment in the study
- •Patients must have proven small airways dysfunction on routine spirometry as reflected by a drop in FEF25-75 and FEF75 of at least 50%. Moreover, patients must have proven small airways dysfunction on MBW as reflected by Sacin >0,120 that is considered abnormal.
排除标准
- •Current smoking
- •Active COPD exacerbation
- •gold stage I and IV
研究组 & 干预措施
Tiotropium+formoterol/beclomethasone
run-in of 4 weeks with thiotropium cross-over after first treatment period of 4 weeks
干预措施: Tiotropium + formoterol/beclometasone (Drug)
tiotropium+placebo
cross-over cfr arm1
干预措施: tiotropium + placebo (Drug)
结局指标
主要结局
Physiologically measured small airway function based on MBW variables (Scond and Sacin) and lung functional variables (N2-washout, studying the plateau of phase III and closing volume).
时间窗: at the end of each treatment period of 4 weeks
After a run-in period of 4 weeks in which all patients will receive Tiotropium 18 pig per day as treatment for their disease, they will be randomized in two groups: one group receiving Tiotropium + placebo and another group receiving Tiotropium + Inuvair 2 puffs bid, for one month. After this treatment period, there will be a wash-out period of 4 weeks (with tiotropium as run-in).
次要结局
- Relate the abnormalities found in tests of small airway function with the findings of probe-based confocal laser endomicroscopy(Before run-in at the end of each treatment period of 4 weeks)