OPEN-LABEL, PROSPECTIVE EXPLORATORY STUDY TO ASSESS THE EFFECTS OF FORMOTEROL AND BECLOMETASONE DIPROPIONATE COMBINATION THERAPY USING A DPI DEVICE ON CENTRAL AND PERIPHERAL AIRWAY DIMENSIONS IN ASTHMATIC PATIENTS.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Computational Fluid Dynamics (CFD)
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 in a dry powder inhaler (NEXThaler®) on central and peripheral airway dimensions in asthmatic patients. Therefore Computational Fluid Dynamics (CFD) will be used. Further more, the effect of this combination therapy on lung function (spirometry, resistance and diffusion), the Asthma Control Test (ACT™) and the Asthma Control Questionnaire (ACQ) will be assessed and the safety will be evaluated.
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 moderate asthma as defined by the current GINA guidelines. Patients can belong to 2 categories:
- •Group 1 (n=15 to 20, at least 4 current smokers): Patients not well controlled (partially controlled or uncontrolled according to the GINA guidelines) when using medium daily dose of ICS or medium dose ICS + long acting inhaled 2-agonists (LABA) (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).
- •Group 2 (n=15 to 20, at least 4 current smokers ): Patients well controlled (according to GINA guidelines) when using medium daily dose of ICS + LABA (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).
- •Male or female patients aged ≥18 years
- •Patients with a documented diagnosis of asthma according to the GINA guidelines
- •Patients with a co-operative attitude and ability to be trained to correctly use the Foster NEXThaler DPI
- •Written informed consent obtained
排除标准
- •Patients treated with extra-fine ICS either alone or with LABA
- •Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period
- •Inability to carry out pulmonary function testing
- •History of near fatal asthma
- •Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
- •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
- •Current 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 4 weeks prior to the screening visit
- •Patients treated with any non-permitted concomitant medication
研究组 & 干预措施
beclomethasone dipropionate + formoterol fumarate
All patients will be treated with the active product. No placebo arm will be used. The active product is a fixed combination containing extra-fine beclometasone dipropionate and formoterol fumarate in a new dry powder inhaler device, NEXThaler® (Chiesi Farmaceutici, Parma, Italy).
干预措施: Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg (Drug)
beclomethasone dipropionate + formoterol fumarate
All patients will be treated with the active product. No placebo arm will be used. The active product is a fixed combination containing extra-fine beclometasone dipropionate and formoterol fumarate in a new dry powder inhaler device, NEXThaler® (Chiesi Farmaceutici, Parma, Italy).
干预措施: CT thorax (Radiation)
结局指标
主要结局
Computational Fluid Dynamics (CFD)
时间窗: CFD will be performed based on the images of 2 CT thorax scans in a dose reduction protocol (1 CT Thorax taken at baseline and 1 CT Thorax taken after 6 months of treatment with the NEXThaler® device).
The parameters that will be obtained with the CFD based imaging and used as primary outcome parameters are: * Total airway resistance for the segmented airways iRtot * Peripheral airway resistance(from 4th bifurcation on) for the segmented airways iRperph * Total airway volume for the segmented airways (iVtot) * Peripheral airway volume (from the 4th bifurcation on) for the segmented airways (iVperiph) * Relative compliance for each lobe (iClobe-rel) * Density of the lung parenchyma given per predefined lung zone (Ldens)
次要结局
- Safety(The safety of the NEXThaler® device will be monitored for the duration of the study, an expected average of 24 weeks.)
- Lung function tests(Lung function tests will be performed at screening (visit 1), after 2 week run-in period both pre and post dose (visit 2), after 3 months treatment (visit 5), after 6 months treatment both pre and post dose (visit 8).)
- Asthma Control(Asthma control will be monitored at screening (visit 1), after 2 week run-in period (visit 2), after 3 months treatment (visit 5), after 6 months treatment (visit 8).)
研究者
Wilfried De Backer
MD PhD
University Hospital, Antwerp