Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using Single Photon Emission Computed Tomography (SPECT) for Comparison With Functional Imaging Using Computer Methods

Study Overview
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Brief Summary
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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.

Official Title
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Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using SPECT-CT for Comparison With Functional Imaging Using Computer Methods

Conditions
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Asthma

Intervention / Treatment
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* Procedure: Computed Tomography
* Procedure: Single Photon Emission Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Procedure: Computed Tomography<br>* 1 low dose CT scan is taken<br>Procedure: Single Photon Emission Computed Tomography<br>* 1 SPECT scan is taken<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lobar aerosol deposition | One of the secondary objectives is to assess the variability in lobar deposition between patients with both methods (CT and SPECT). |  | 
| Sample size estimation for future studies | Another secondary objective of this study is to establish a basis for a power calculation to determine adequate sample size for possible prospective studies. |  |