Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using SPECT-CT for Comparison With Functional Imaging Using Computer Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Deposition of inhaled aerosol
研究概览
简要总结
In this open prospective study, 6 well controlled asthmatic patients will undergo a high-resolution multi-slice computed tomography (CT) scan, lung function tests and a SPECT scan to obtain patient specific geometries of the central and peripheral small airways, patient specific boundary conditions and the in-vivo spatial distribution of inhaled aerosols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 well controlled asthma as defined by the current GINA guidelines
- •Male or female patients aged ≥18 years
- •Patients with a documented positive response to the reversibility test (i.e. FEV1 increase ≥ 12% and 200mL from baseline value after 4 puffs of 100 µg of inhaled salbutamol pMDI) 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
- •Written informed consent obtained
- •Patients maintained on stable respiratory medication for 4 weeks prior to visit 1
排除标准
- •Patients who are pregnant or are breast-feeding
- •Inability to carry out pulmonary function testing
- •Diagnosis of COPD as defined by the current GOLD guidelines
- •History of near fatal asthma
- •Hospitalization due to exacerbation or respiratory infection of the airways 4 weeks prior to visit 1
- •Current smokers or ex-smokers
- •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
- •Cancer or any other chronic disease with poor prognosis and/or affecting patient status
- •BMI ≥ 35 kg/m2
- •Patients treated with CPAP or BiPAP
- •Known active tuberculosis
- •A history of cystic fibrosis, central bronchiectasis or interstitial lung disease
- •A history of thoracotomy with pulmonary resection
- •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
结局指标
主要结局
Deposition of inhaled aerosol
The primary objective of this study is to correlate the deposition distribution of inhaled aerosol obtained using computer methods through comparison with in-vivo SPECT data. The computer methods yield the concentration of particles entering and depositing in a lung lobe based on flow and particle behaviour simulation. The SPECT data yields the same parameter, i.e. particle concentration within each lung lobe, through scintigraphy assessment of the inhaled aerosols.
次要结局
- Lobar aerosol deposition
- Sample size estimation for future studies