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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966758
• Other study ID #: PML_DOC_0901
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: September 15, 2010
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2010
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Computed Tomography
1 low dose CT scan is taken
• Single Photon Emission Computed Tomography
1 SPECT scan is taken

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	Lobar aerosol deposition	One of the secondary objectives is to assess the variability in lobar deposition between patients with both methods (CT and SPECT).		No
Secondary	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.		No