AsthmaNCT00966758
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
A study testing Computed Tomography and Single Photon Emission Computed Tomography in people with Asthma, run by University Hospital, Antwerp at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Computed Tomography and Single Photon Emission Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using SPECT-CT for Comparison With Functional Imaging Using Computer Methods
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
- Being tested
- Computed Tomography, Single Photon Emission Computed Tomography
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
1 low dose CT scan is taken
Single Photon Emission Computed TomographyProcedure or surgery
1 SPECT scan is taken
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: Computed Tomography; Procedure: Single Photon Emission Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Investigators
- Wilfried A De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966758
- Sponsor's protocol ID
- PML_DOC_0901
- Status last verified
- Sep 2010
- First submitted
- 26 Aug 2009
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using SPECT-CT for Comparison With Functional Imaging Using Computer Methods
- ClinicalTrials.gov ID
- NCT00966758
- Acronym / sponsor ID
- PML_DOC_0901
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Computed Tomography, Procedure: Single Photon Emission Computed Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography1 low dose CT scan is taken | Procedure or surgery | 1 |
| Single Photon Emission Computed Tomography1 SPECT scan is taken | Procedure or surgery | 1 |
Primary outcome
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.
2 secondary outcomes
Lobar aerosol deposition
Sample size estimation for future studies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried A De Backer, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography and Single Photon Emission Computed Tomography in people with Asthma, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deposition of inhaled aerosol. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2010.