Back to resultsOpen, 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
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Computed Tomography
Single Photon Emission Computed Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma
Eligibility Criteria
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
Sites / Locations
- University Hospital Antwerp
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00966758
First Posted
August 26, 2009
Last Updated
September 15, 2010
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT00966758
Brief Title
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
Official Title
Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using SPECT-CT for Comparison With Functional Imaging Using Computer Methods
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Intervention Description
1 low dose CT scan is taken
Intervention Type
Procedure
Intervention Name(s)
Single Photon Emission Computed Tomography
Intervention Description
1 SPECT scan is taken
Primary Outcome Measure Information:
Title
Deposition of inhaled aerosol
Description
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 Measure Information:
Title
Lobar aerosol deposition
Description
One of the secondary objectives is to assess the variability in lobar deposition between patients with both methods (CT and SPECT).
Title
Sample size estimation for future studies
Description
Another secondary objective of this study is to establish a basis for a power calculation to determine adequate sample size for possible prospective studies.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried A De Backer, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
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
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