Asthma
Conditions
Brief summary
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.
Interventions
PROCEDUREComputed Tomography
1 low dose CT scan is taken
PROCEDURESingle Photon Emission Computed Tomography
1 SPECT scan is taken
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with well controlled asthma as defined by the current GINA guidelines 2. Male or female patients aged ≥18 years 3. 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 4. Patients with a co-operative attitude 5. Written informed consent obtained 6. Patients maintained on stable respiratory medication for 4 weeks prior to visit 1
Exclusion criteria
1. Patients who are pregnant or are breast-feeding 2. Inability to carry out pulmonary function testing 3. Diagnosis of COPD as defined by the current GOLD guidelines 4. History of near fatal asthma 5. Hospitalization due to exacerbation or respiratory infection of the airways 4 weeks prior to visit 1 6. Current smokers or ex-smokers 7. 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 8. Cancer or any other chronic disease with poor prognosis and/or affecting patient status 9. BMI ≥ 35 kg/m2 10. Patients treated with CPAP or BiPAP 11. Known active tuberculosis 12. A history of cystic fibrosis, central bronchiectasis or interstitial lung disease 13. A history of thoracotomy with pulmonary resection 14. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study 15. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Outcome results
None listed