NCT01204034已完成3 期
Open-label, Prospective Exploratory Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in COPD Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Total airway volume for the segmented airways
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 COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented COPD based on the following criteria:
- •Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC < 0.70
- •Male or female patients aged ≥ 40 years
- •Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines
- •Patients who present
- •Moderate COPD with an FEV1 between 50 and 80% of predicted GOLD 2)
- •Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)
- •Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)
- •Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
- •Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
- •Written informed consent obtained
排除标准
- •Pregnant or lactating females or females at risk of pregnancy
- •Unstable patients who developed an exacerbation during the last 4 weeks
- •Inability to carry out pulmonary function testing
- •Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines
- •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 4 weeks prior to the screening visit
- •Patients treated with any non-permitted concomitant medication
研究组 & 干预措施
Inuvair
Other
干预措施: Inuvair (Drug)
结局指标
主要结局
Total airway volume for the segmented airways
时间窗: at baseline and after 6 months of treatment
Peripheral airway resistance (from 4th bifurcation on) for the segmented airways
时间窗: at baseline and after 6 months of treatment
Peripheral airway volume (from the 4th bifurcation on) for the segmented airways
时间窗: at baseline and after 6 months of treatment
Relative compliance for each lobe
时间窗: at baseline and after 6 months of treatment
Density of the lung parenchyma given per predefined lung zone
时间窗: at baseline and after 6 months of treatment
Total airway resistance for the segmented airways
时间窗: at baseline and after 6 months of treatment
次要结局
- BODE index(at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8))
- COPD assessment test(at screening (visit 1), at baseline (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment (visit 8))
- Borg CR10 Scale(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Adverse events as a measure of safety(during the study patients will record record each day taken medication and any possible comments on the daily diary cards)
- Forced expiratory volume in 1 second (FEV1)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Forced Vital Capacity (FVC)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Peak Expiratory Flow (PEF)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Maximum expiratory flow rate at 50% of vital capacity (MEF50)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Maximal expiratory flow rate at 25% of vital capacity (MEF25)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Vital capacity (VC)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Inspiratory vital capacity (IVC)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Functional residual capacity (FRC)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Total Lung Capacity (TLC)(At screening, at baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Airway resistance (Raw)(At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
- Specific airways conductance (SGaw)(At baseline both pre and post dose (visit 2), after 3 months of treatment (visit 5) and after 6 months of treatment both pre and post dose (visit 8))
研究者
Wilfried De Backer
MD PhD
University Hospital, Antwerp
研究点 (1)
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