1. Study identification
EU PAS Register NumberEUPAS32899
Official titleSevere Asthma Super-Responders Delphi Exercise
Study title acronym
Study typeObservational study
Brief description of the studyThis study aims to survey health care professionals in multiple countries to define a consensus-based definition of a severe asthma ‘super-responder’. Primary objectives of this study are to follow a Delphi process to define an international consensus-based definition of a ‘super-responder’, targeting health care professionals in multiple countries who treat severe asthma. The Delphi process will comprise of two or three iterative rounds of electronic surveys to gather anonymised opinions on the definition of a super-responder. De-identified data will be collected after each round and summary statistics completed to identify if consensus has been reached for each topic.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Professor
Last name Upham
First name John
Is this study being carried out with the collaboration of a research network?
Yes
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
Argentina
Australia
Belgium
Bulgaria
Canada
Colombia
Denmark
Estonia
Finland
France
Germany
Greece
Iceland
India
Italy
Kuwait
Mexico
Netherlands
New Zealand
Portugal
Saudi Arabia
Singapore
Spain
Taiwan
Thailand
United Arab Emirates
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/06/201918/06/2019
Start date of data collection04/09/201904/09/2019
Start date of data analysis03/02/2020
Date of interim report, if expected
Date of final study report21/02/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherObservational Pragmatic Research Institute (OPI)100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Upham
First name John
Address line 1Translational Research Institute
Address line 237 Kent Street Woolloongabba
Address line 3
CityBrisbane, QLD
Postcode
CountryAustralia
Phone number (incl. country code)61734438065
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Upham
First name John
Address line 1Translational Research Institute
Address line 237 Kent Street Woolloongabba
Address line 3
CityBrisbane, QLD
Postcode
CountryAustralia
Phone number (incl. country code)61734438065
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects118
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Online survey
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
Define an international consensus-based definition of a ‘super-responder’ using a Delphi process and targeting health care professionals in multiple countries who treat severe asthma.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Delphi exercise
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Summary statistics for continuous variables will include: Sample size (n), Mean/standard deviation, Range (minimum – maximum), Median and Inter-quartile range. Summary statistics for categorical variables will include Sample size (n), range (if applicable), count and percentage by category (distribution). Descriptive statistics on demographic characteristics will be provided for continuous and categorical variables.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted