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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04585997
Registration number
NCT04585997
Ethics application status
Date submitted
30/09/2020
Date registered
14/10/2020
Date last updated
14/10/2020
Titles & IDs
Public title
Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".
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Scientific title
How to "Choosebetweenamab" for Severe Asthma, Comparing Treatment With Mepolizumab and Omalizumab for Patients With Severe Allergic and Eosinophilic Asthma.
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Secondary ID [1]
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18/08/15/3.01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Eosinophilic Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Respiratory
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Other respiratory disorders / diseases
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Blood
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Haematological diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mepolizumab
Treatment: Drugs - Omalizumab
Active comparator: Mepolizumab - Mepolizumab
Active comparator: Omalizumab - Omalizumab
Treatment: Drugs: Mepolizumab
Mepolizumab 100mg subcutaneous injection monthly for 6 months
Treatment: Drugs: Omalizumab
Omalizumab subcutaneous injection every 2-4 weeks (dosage determined by the Omalizumab nomogram).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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ACQ5
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Assessment method [1]
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The primary outcome will be Asthma control questionairre (ACQ)5, adjusted for baseline ACQ5
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Timepoint [1]
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Assessed after 6 months treatment
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Secondary outcome [1]
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Exacerbations
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Assessment method [1]
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Number of Exacerbations, requiring change in oral corticosteroids, with either a course of prednisone for at least 3 days, or in those on regular OCS an increase in dose of at least 50% for at least 3 days. Patient reported monthly
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Timepoint [1]
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every month up to 6 months after treatment commenced
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Secondary outcome [2]
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Time to first exacerbation reported, by patient or health provider
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Assessment method [2]
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Time to first exacerbation reported, by patient or health provider
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Timepoint [2]
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every month up to 6 months after treatment commenced
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Secondary outcome [3]
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Hospital admissions
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Assessment method [3]
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Number of admissions to hospital patient reported
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Timepoint [3]
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every month up to 6 months after treatment commenced
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Secondary outcome [4]
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Oral corticosteroids
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Assessment method [4]
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Reduction in dose of regular OCS, confirmed by health care provider and patient reported
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Timepoint [4]
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every month up to 6 months after treatment commenced
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Secondary outcome [5]
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Spirometry
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Assessment method [5]
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Change in spirometry, FEV1., measured at time treatment commences and 6 months after treatment
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Timepoint [5]
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every month up to 6 months after treatment commenced
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Secondary outcome [6]
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Continuing treatment
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Assessment method [6]
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Proportion continuing on Australian PBS treatment (successful treatment). The number at the conclusion of the 6 months that will continue treatment. reported by health provider
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Timepoint [6]
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6 months post intervention
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Secondary outcome [7]
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Adverse events
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Assessment method [7]
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Adverse events; i.e. injection site reaction, reported. Headaches, reported, rash, reported, allergic reaction, reported. Any other relevant adverse event report. Patient and health care provider reported
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Timepoint [7]
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every month up to 6 months after treatment commenced
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Secondary outcome [8]
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Emergency department presentation
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Assessment method [8]
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Number of emergency department presentations, patient and health care provider reported
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Timepoint [8]
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every month up to 6 months after treatment commenced
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Secondary outcome [9]
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Overall dose of oral corticosteroids
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Assessment method [9]
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Overall dose of systemic corticosteroids used during the 6 months after treatment commences. Patients and health care provided
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Timepoint [9]
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6 months post intervention
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Secondary outcome [10]
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Change in gene expression measured by single cell RNA sequencing of peripheral blood cells (ISS 11066)
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Assessment method [10]
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ISS 11066 is a substudy of Choosebetweenamab using transcriptomic single cell sequencing of patient white blood cells from both treatment groups at baseline. The data generated from this will be compared to the above clinical outcomes at all follow-up time points. Single cell gene expression and cell type cluster patterning delineated through bioinformatic data processing will be inputted with clinical outcomes into a GLM to identify baseline predictors (gene and cell type) of treatment effect
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Timepoint [10]
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Measured prior to treatment and clinical outcomes at 6 months after treatment
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Eligibility
Key inclusion criteria
* Participants must have a duration of asthma of greater than one year.
* They must have confirmed asthma defined as: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12%, and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days.
* They must have evidence of poor asthma control despite optimal ICS and long acting beta agonist (LABA), be treated by a respiratory physician or immunologist, and have demonstrated acceptable adherence and inhaler technique. Poor control is defined as: evidence of an FEV1 <80% of predicted in the last year on at least one occasion; treatment with OCS, either daily for at least 6 weeks, or a cumulative dose of OCS of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
* In addition they must demonstrate an: (a) an Asthma Control Questionnaire (ACQ-5)38 score of at least 2.0, as assessed in the previous month, and (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, or 1 severe asthma exacerbation, requiring documented use of OCS initiated or increased for at least 3 days, or parenteral corticosteroids prescribed/supervised by a physician.
* They must also demonstrate evidence of a dual allergic/ eosinophilic phenotype. This is defined as: a total serum IgE >30IU/mL, past or current evidence of atopy documented by skin prick testing or radioallergosorbent assay, and the participant must have a blood eosinophil count greater than or equal to 300 cells per microlitre in the last 6 weeks.
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Minimum age
12
Years
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Maximum age
85
Years
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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
* Do not fulfil inclusion criteria
* Unable to attend appointments
* Significant psychiatric illness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2022
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton
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Recruitment postcode(s) [1]
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2305 - New Lambton
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Newcastle, Australia
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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GlaxoSmithKline
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab is an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) used in the treatment of severe allergic eosinophilic asthma The investigators propose that in patients with the dual phenotypes of severe allergic and eosinophilic asthma, that Mepolizumab is as effective as Omalizumab. However, this trial will also identify key clinical biomarkers that will clarify which patients will respond best to each of these interventions. This study will be the first direct clinical comparison of these agents and will apply expert clinical characterization, along with cutting edge biotechnology to better inform treatment choices for severe asthma. This is an important and urgent management problem facing the Australian pharmaceutical scheme, where imprecision in prescribing will result in reduced clinical effectiveness as well as substantial and sustained costs.
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Trial website
https://clinicaltrials.gov/study/NCT04585997
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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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Peter Wark, MBBS/PhD
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Address
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University of Newcastle and Hunter New England Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Peter Wark, MBBS/PhD
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Address
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Country
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Phone
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(02) 40420110
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Informed consent form
https://cdn.clinicaltrials.gov/large-docs/97/NCT04585997/ICF_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/97/NCT04585997/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04585997
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