Open-Label, Prospective Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in Asthmatic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Differences in airway dimension
研究概览
简要总结
The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in asthmatic patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and resistance) and subjective asthma control score as well as the safety of this combination will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with asthma as defined by the current Global INitiative for Asthma (GINA) guidelines:
- •Male or female patients aged ≥18 years
- •Patients with a documented positive response to the reversibility test within the 12 months preceding the screening visit or performed at screening visit after a wash-out of 2 days for long acting β2 agonists or a documented positive response to the methacholine challenge test
- •Patients with a co-operative attitude and ability to be trained to correctly use the pressurized Metered Dose Inhaler (pMDI)
- •Written informed consent obtained
排除标准
- •Pregnant or lactating females or females at risk of pregnancy
- •Inability to carry out pulmonary function testing
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the current Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines
- •History of near fatal asthma
- •Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
- •Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day
- •Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
- •Patients with a QTc interval (Bazett's formula) at the screening visit Electrocardiogram (ECG) test >450 msec
- •Cancer or any other chronic disease with poor prognosis and /or affecting patient status
- •History of alcohol or drug abuse
- •Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- •Patients who received any investigational new drug within the last 8 weeks prior to the screening visit
- •Patients treated with any non-permitted concomitant medication
研究组 & 干预措施
Inuvair
干预措施: Inuvair (Drug)
结局指标
主要结局
Differences in airway dimension
时间窗: airway dimension will be measured at visit 2 and visit 7
The primary objective of this study is to evaluate the effect of the combination therapy on central and peripheral airway dimensions with CFD. The following primary outcome parameters will be determined: * Total airway resistance for the segmented airways * Peripheral airway resistance(from 4th bifurcation on) for the segmented airways * Total airway volume for the segmented airways * Peripheral airway volume (from the 4th bifurcation on) for the segmented airways * Relative compliance for each lobe * Density of the lung parenchyma given per predefined lung zone
次要结局
- Lung function tests: dynamic lung volumes, static lung volumes and airway resistances(lung function tests will be perfomed at te following visits: screening, visit 1 (2 weeks after screening), visit 3 (6 weeks after screening), visit 5 (14 weeks after screening) and visit 7 (26 weeks after screening))
- Subjective asthma control score(Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7)
- Exhaled Nitric Oxide (NO)(Exhaled NO will be measured on visit 2, 3, 5 and 7)
- Adverse events as a measure of safety(Follow up of adverse events will be done during the entire study duration)
研究者
Wilfried De Backer
MD PhD
University Hospital, Antwerp