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Trial registered on ANZCTR
Registration number
ACTRN12617001275358
Ethics application status
Approved
Date submitted
17/08/2017
Date registered
5/09/2017
Date last updated
13/08/2019
Date data sharing statement initially provided
13/08/2019
Date results information initially provided
13/08/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Can Functional Lung Ventilation Imaging in Asthma and Chronic obstructive pulmonary disease identify response to treatment.
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Scientific title
Can functional lung ventilation imaging identify treatable traits in obstructive airway disease?
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Secondary ID [1]
292672
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nil known
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Universal Trial Number (UTN)
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Trial acronym
ITT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Severe asthma
304417
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Chronic obstructive pulmonary disease
304418
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Condition category
Condition code
Respiratory
303746
303746
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0
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Asthma
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Respiratory
303747
303747
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Functional lung ventilation imaging with quantification using Technegas will be used. Tomographic pulmonary scintigraphy (ventilation/perfusion single photon emission computed tomography: V/P SPECT) is a nuclear medicine investigation that gives a 3dimensional functional map of the ventilation and perfusion of the lungs and shows how these are affected by disease. The participant will breathe in a very small amount of nanoparticle suspension for ventilation images and be given an injection of radioactive material, called Technetium99mTc, for the perfusion images. The VQ scan takes less than an hour. A low radiation CT scan will also be performed as part of the imaging.
All 100 participants will undergo the baseline imaging. A subgroup of 30 participants will receive a second imaging session after 12 weeks of add-on therapy. This treatment will be part of their current clinical practice at the John Hunter Hospital Respiratory Clinic, under the supervision of the patient’s treating physician.
Participants in the sub-group will receive either Mepolizumab, Omalizumab or Macrolide antibiotics. Mepolizumab is administered by subcutaneous injection of 150mg every 4 weeks. Omalizumab will also be administered by subcutaneous injections every 2 weeks or 4 weeks with the patient's pre-treatment serum total IgE level (IU/mL) and body weight (lb or kg) being used to determine doses (mg) and dosing frequency. The dosing table can be found at: https://www.xolair.com/allergic-asthma/hcp/determining-the-dose.html.. Macrolide antibiotics will be administered as oral azithromycin as either 250mg daily or 500mg, 3 times per week depending on the patient's preference and perceived adherence.
The overall time-frame of each add-on therapy may vary between participants, however the second imaging scan will happen after they have undergone 12 weeks of their treatment.
Medication adherence will be routinely assessed by respiratory nurses and clinicians at each clinic review by open ended questions. Adherence will also be checked by the clinical research assistant at the 12-week follow-up study visit.
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Intervention code [1]
298907
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Diagnosis / Prognosis
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Intervention code [2]
298944
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Treatment: Devices
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Intervention code [3]
299020
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Ventilation heterogeneity among patients with severe obstructive airways diseases as assessed using technegas functional lung ventilation and perfusion with imaging and quantification
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Assessment method [1]
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Timepoint [1]
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0 weeks (all participants)
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Primary outcome [2]
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Technegas functional lung ventilation and perfusion imaging quantification responsiveness to change following intervention in patients with severe obstructive airways diseases.
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Assessment method [2]
303169
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Timepoint [2]
303169
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12 weeks (30 participants)
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Secondary outcome [1]
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ACQ score
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Assessment method [1]
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Timepoint [1]
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0 weeks (all participants) and 12 weeks (30 participants)
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Eligibility
Key inclusion criteria
Adults (greater than or equal to 18 years) with severe treatment refractory asthma defined according to ATS/ERS criteria:
-Asthma which requires treatment with guidelines-suggested medications for GINA steps 4-5 (high dose ICS and LABA or leukotriene modifier/theophylline) for the previous year or systemic corticosteroids for greater than or equal to 50% of the previous year to prevent it from becoming “uncontrolled” or which remains “uncontrolled” despite this therapy
-Uncontrolled asthma defined as at least one of the following:
*Poor symptom control: ACQ consistently > 1.5, ACT < 20
*Frequent severe exacerbations: 2 or more bursts of systemic corticosteroids (greater than 3 days each) in the previous year
*Serious exacerbations: at least one hospitalisation, ICU stay or mechanical ventilation in the previous year
*Airflow limitation: after appropriate bronchodilator withhold FEV1 < 80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal)
OR
Adults (greater than or equal to 18 years) with obstructive airways disease (either asthma or COPD) who are to be treated with add on therapies (macrolides, monoclonal antibody therapies or itraconazole). This includes moderate or severe asthma or COPD, with persistent symptoms, and/or frequent exacerbations. Exacerbations will be defined as indicated below.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
•Inability to attend study visits.
•Current lung cancer or other blood, lymphatic or solid organ malignancy
•Diagnosis with primary respiratory disease other than asthma or COPD (e.g. active tuberculosis, pulmonary fibrosis)
•Expected prognosis poor <3 months survival
•Pregnancy or breast-feeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
A cross-sectional analytic design will be used to assess baseline imaging sessions in all participants. A before-after clinical trial will be used to assess a subgroup of participants at a second imaging session after they undergoes a standard treatment as part of routine clinical practice.
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Summary statistics will be reported for the cross sectional characterisation study. Parametric results will be reported as mean (SD) and non-parametric results as median (q1,q3).
To compare differences in before and after treatment responses of continuous variables, we will perform Students¹ paired t-tests for parametric data and the two-sample Wilcoxon Rank Sum for non parametric data, and the Chi-squared or Fisher¹s exact test for categorical variables. Associations will be determined using Pearson¹s or Spearman¹s correlation coefficients as appropriate.
Results will reported as significant when p<0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/09/2017
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Actual
7/09/2017
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Date of last participant enrolment
Anticipated
6/09/2018
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Actual
3/04/2019
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Date of last data collection
Anticipated
5/12/2018
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Actual
31/07/2019
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
8849
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John Hunter Hospital - New Lambton
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Recruitment postcode(s) [1]
16998
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2305 - New Lambton
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Cyclopharm Limited
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Address [1]
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Unit 4, The Crescent Kingsgrove, NSW 2208
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Country [1]
297312
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Australia
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Primary sponsor type
Individual
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Name
Vanessa McDonald
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Address
Level 2, Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
296282
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Address [1]
296282
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Country [1]
296282
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Hunter New England Human Research Ethics
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Ethics committee address [1]
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Lookout Road, New Lambton Heights, NSW 2208
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Ethics committee country [1]
298417
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Australia
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Date submitted for ethics approval [1]
298417
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14/12/2016
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Approval date [1]
298417
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07/04/2017
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Ethics approval number [1]
298417
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16/12/14/4.02
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Summary
Brief summary
Chronic Obstructive Pulmonary Disease and Severe Asthma are chronic obstructive airway diseases associated with a high disease burden. They are complex diseases that can be complicated by significant comorbidity. A new and emerging approach to these conditions is to focus on the identification and treatment of the processes that underlie individual disease. These components are termed ‘treatable traits’.
An important aspect of the treatable traits approach is objective monitoring to select and continue therapy. Most current monitoring approaches are assessed using nonobjective
measures, that do not capture improvements after treatment.
Functional lung ventilation imaging with quantification using Technegas may address this clinical need. Tomographic pulmonary scintigraphy (ventilation/perfusion single photon emission computed tomography: V/P SPECT) is a nuclear medicine investigation that gives a 3dimensional functional map of the ventilation and perfusion of the lungs and shows how these are affected by disease.
We believe that this new imaging approach may be a useful objective measure of disease and treatment response in severe asthma and COPD.
In the current study, we aim to quantify:
1. Whether functional lung ventilation technology can objectively quantify ventilation heterogeneity in patients with severe obstructive airway disease (asthma or COPD).
2. Determine whether functional lung ventilation imaging can be used to quantify response to therapies.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Vanessa McDonald
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Address
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Level 2, Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
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Country
77018
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Australia
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Phone
77018
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+61 2 4042 0146
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Fax
77018
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+61 2 4042 0046
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Email
77018
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[email protected]
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Contact person for public queries
Name
77019
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Miss Gabrielle LeBrocq
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Address
77019
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Level 2, Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
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Country
77019
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Australia
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Phone
77019
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+61 2 4042 0131
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Fax
77019
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+61 2 4042 0046
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Email
77019
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[email protected]
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Contact person for scientific queries
Name
77020
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Prof Peter Gibson
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Address
77020
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John Hunter Hospital, Respiratory and Sleep Medicine
Locked Bag 1, HMRC NSW 2310
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Country
77020
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Australia
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Phone
77020
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+61 2 4042 0143
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Fax
77020
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+61 2 4042 0046
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Email
77020
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymised demographic and primary and secondary outcome data underlying published results
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When will data be available (start and end dates)?
Following publication - no end date
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Available to whom?
Case by case basis at the discretion of the primary sponsor
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Available for what types of analyses?
Individual patient data meta-analysis
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How or where can data be obtained?
Access subject to approvals by Principal Investigator
Professor Vanessa McDonald 02 40420146
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Imaging for precision medicine: can V-P SPECT measure mepolizumab response in asthma?
2021
https://doi.org/10.1002/rcr2.717
N.B. These documents automatically identified may not have been verified by the study sponsor.
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