Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001271695
Ethics application status
Approved
Date submitted
8/11/2023
Date registered
6/12/2023
Date last updated
6/12/2023
Date data sharing statement initially provided
6/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Further Understanding asThma REmission: the FUTURE research program
Scientific title
An Australian Mepolizumab Registry-based research program with a series of embedded cross-sectional cohort studies to investigate the clinical, immunological, economic and health literacy characteristics of long-term remission of severe asthma treated with mepolizumab
Secondary ID [1] 310879 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FUTURE
Linked study record
ACTRN12618001497291 - Australian Mepolizumab Registry

Health condition
Health condition(s) or problem(s) studied:
Severe Asthma 331928 0
Condition category
Condition code
Respiratory 328657 328657 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study includes several embedded research projects:

1. Analysis of an existing registry-based dataset (no active participation, involves analysis of data already collected as part of ACTRN12618001497291).
2. A cross-sectional observational study conducted in four groups of participants:
a. Severe eosinophilic asthma not treated with a monoclonal antibody therapy
b. Severe eosinophilic asthma treated with mepolizumab in remission
c. Severe eosinophilic asthma treated with mepolizumab not in remission
d. Participants with no demonstrable obstructive airways disease.
3. A health economic evaluation of treatment-induced remission of severe asthma
4. A qualitative study of severe asthma patients treated with mepolizumab seeking their perspectives on asthma remission.

Participants in groups a-d will attend a single cross-sectional biospecimen collection study visit. Each study visit will involve collection of blood, induced sputum and nasal biopsy samples, spirometry (lung function) tests, measurement of height and weight. The participant will also complete some questionnaires to gain information about general health or quality of life, medical history and medications and asthma symptoms. Study visits are anticipated to be 2-3 hours in duration. The study visit will be conducted by trained Research Staff.

For participants in the qualitative study, this will involve a one-on-one conversation with a research staff member in the form of an interview. The interview will take up to 2 hours and will be audio-recorded. Interviews will either take place face-to-face at Hunter Medical Research Institute, by phone or online. Qualitative research interviews will occur on a separate occasion to the biospecimen collection visit, if participants have consented to participate in both.

All participants will consent to:
A. Completing questionnaires to obtain research data
B. Allowing research personnel to access their medical record (NSW Hunter New England local health district electonic medical records).

Participants will consent to either:
C. Completing the tests involved in the study; and/or D. Attending a one-on-one research interview conducted by study personnel.

Participants may optionally consent to:
E. Storage of biospecimens for use in future research studies relating to asthma and respiratory disease.
Intervention code [1] 327302 0
Diagnosis / Prognosis
Comparator / control treatment
Participants with no demonstrable obstructive airways disease.
Control group
Active

Outcomes
Primary outcome [1] 336456 0
Remission
Timepoint [1] 336456 0
Assessed at 24 months or more of mepolizumab treatment.
Secondary outcome [1] 428469 0
Blood gene expression - exploratory outcome
Timepoint [1] 428469 0
Assessed at biospecimen collection study visit
Secondary outcome [2] 428470 0
plasma immune protein concentrations - exploratory outcome
Timepoint [2] 428470 0
Assessed at biospecimen collection study visit
Secondary outcome [3] 428471 0
peripheral blood mononuclear cell (PBMC) innate immune cytokine production
Timepoint [3] 428471 0
Assessed at biospecimen collection study visit
Secondary outcome [4] 428472 0
sputum cell count
Timepoint [4] 428472 0
Assessed at biospecimen collection study visit
Secondary outcome [5] 428473 0
sputum gene expression - exploratory outcome
Timepoint [5] 428473 0
Assessed at biospecimen collection study visit
Secondary outcome [6] 428474 0
bronchial hyperresponsiveness
Timepoint [6] 428474 0
Assessed at biospecimen collection study visit
Secondary outcome [7] 428475 0
data saturation of themes describing patient perspectives of asthma remission
Timepoint [7] 428475 0
Assessed at one-off qualitative study visit
Secondary outcome [8] 429211 0
Nasal biopsy gene expression - exploratory outcome
Timepoint [8] 429211 0
Assessed at one-off biospecimen collection study visit
Secondary outcome [9] 429673 0
Health economics of remission
Timepoint [9] 429673 0
Assessed at 24 months or more of mepolizumab treatment

Eligibility
Key inclusion criteria
Primary outcome: Participants enrolled in Australian Mepolizumab Registry (ACTRN12618001497291) who have completed 2 years of treatment.

Cross-sectional biospecimen and qualitative studies:
1. Group a: participants meeting Australian PBS criteria for commencement of mepolizumab therapy for severe eosinophilic asthma.
2. Group b: participants with severe asthma who have received mepolizumab treatment for 2 years who meet remission criteria.
3. Group c: participants with severe asthma who have received mepolizumab treatment for 2 years who do not meet remission criteria.
4. Group d: participants without current diagnosis of lung disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group a: Participant must not have received another PBS-subsidised biological medicine prescribed for severe asthma in the prior 3 months.

All groups: No respiratory infection in prior 4 weeks to visit, and for participants with asthma (groups a-c) no exacerbation of asthma in prior 4 weeks to visit.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315139 0
Commercial sector/Industry
Name [1] 315139 0
Glaxo Smith Kline
Country [1] 315139 0
United Kingdom
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 317158 0
None
Name [1] 317158 0
Address [1] 317158 0
Country [1] 317158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314077 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 314077 0
Locked Bag 1 New Lambton NSW 2305
Ethics committee country [1] 314077 0
Australia
Date submitted for ethics approval [1] 314077 0
02/10/2023
Approval date [1] 314077 0
17/10/2023
Ethics approval number [1] 314077 0
2023/ETH01782

Summary
Brief summary
People with severe asthma experience high symptom burden and frequent severe asthma attacks (termed exacerbations). In the last decade new biologic (antibody) treatments, including mepolizumab, have become available for severe asthma. Clinicians now recognise that mepolizumab treatment results in almost complete suppression of symptoms and exacerbations, termed remission, in around a quarter of patients. Remission of severe asthma is a relatively new concept, and further understanding of numerous aspects of remission is now required to promote remission as a clinical target and to further raise remission rates on treatment. To address this, in this study we aim to understand the clinical, immunological, economic and health literacy characteristics of long-term remission of severe asthma treated with mepolizumab.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130326 0
Dr Michael Fricker
Address 130326 0
Level 2, Hunter Medical Research Institute 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 130326 0
Australia
Phone 130326 0
+61 2 4042 0207
Fax 130326 0
+61 2 4042 0046
Email 130326 0
michael.fricker@newcastle.edu.au
Contact person for public queries
Name 130327 0
Dr Michael Fricker
Address 130327 0
Level 2, Hunter Medical Research Institute 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 130327 0
Australia
Phone 130327 0
+61 2 4042 0207
Fax 130327 0
+61 2 4042 0046
Email 130327 0
michael.fricker@newcastle.edu.au
Contact person for scientific queries
Name 130328 0
Dr Michael Fricker
Address 130328 0
Level 2, Hunter Medical Research Institute 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 130328 0
Australia
Phone 130328 0
+61 2 4042 0207
Fax 130328 0
+61 2 4042 0046
Email 130328 0
michael.fricker@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Unprocessed transcriptomic datasets.
When will data be available (start and end dates)?
From date of publication, with no end date.
Available to whom?
Public.
Available for what types of analyses?
Transcriptomic analysis.
How or where can data be obtained?
Unprocessed transcriptomics data will be uploaded to the NCBI gene expression omnibus (https://www.ncbi.nlm.nih.gov/geo/) upon publication, where it will be publically available for download indefinitely.


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
No additional documents have been identified.