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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00966758
First received: August 26, 2009
Last updated: September 15, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Asthma
Procedure: Computed Tomography
Procedure: Single Photon Emission Computed Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using SPECT-CT for Comparison With Functional Imaging Using Computer Methods

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Deposition of inhaled aerosol [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    Another secondary objective of this study is to establish a basis for a power calculation to determine adequate sample size for possible prospective studies.


Enrollment: 6
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: Computed Tomography
1 low dose CT scan is taken
Procedure: Single Photon Emission Computed Tomography
1 SPECT scan is taken

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966758

Locations
Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Wilfried A De Backer, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Prof Dr Wilfried De Backer, University Hospital Antwerp, Department of Respiratory Medicine
ClinicalTrials.gov Identifier: NCT00966758     History of Changes
Other Study ID Numbers: PML_DOC_0901
Study First Received: August 26, 2009
Last Updated: September 15, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014