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

NCT00966758 | Completed

• 1 other identifier: PML_DOC_0901
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Lobar aerosol deposition

• Sample size estimation for future studies

Study Arms (1)

1

OTHER

Procedure: Computed Tomography; Procedure: Single Photon Emission Computed Tomography

Interventions

Computed Tomography PROCEDURE

1 low dose CT scan is taken

1

Single Photon Emission Computed Tomography PROCEDURE

1 SPECT scan is taken

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wilfried A De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

BE (1)