Status: Ongoing
First registered on:
12/09/2019
Last updated on:
31/12/2019
1. Study identification
EU PAS Register NumberEUPAS31355
Official titleThe Characterization and Comparison of Eosinophilic and Non-eosinophilic Phenotypes of Severe Asthma
Study title acronymEosinophilic and Non-eosinophilic Phenotypes
Study typeObservational study
Brief description of the studyThis cross-sectional study design is the first step to better understand and assess the presence of eosinophilic and non-eosinophilic asthma phenotypes using known constructs of severe asthma epidemiology. Firstly, most likely non-eosinophilic asthma patients will be identified followed by discerning eosinophilic asthma patients with most likely versus likely degrees of confidence. The characteristics of eosinophilic and non-eosinophilic phenotypes will be compared to a benchmark (published results from a similar study population). Data for this study will be sourced from the International Severe Asthma Registry (ISAR). Parallel analyses using a primary care observational database, the Optimum Patient Care Research Database (OPCRD), will be conducted for providing a benchmark for comparison.
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
Centre nameOptimum Patient Care Global Limited (OPCG)
Centre locationUK
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
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
Bulgaria
Canada
Greece
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/201830/04/2018
Start date of data collection31/08/201815/10/2018
Start date of data analysis01/03/201915/03/2019
Date of interim report, if expected
Date of final study report31/01/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca50
Charities
Government body
Research councils
EU funding scheme
OtherOPCG50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2
Address line 3
CityOakington, Cambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2
Address line 3
CityOakington, Cambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057
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)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects5000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Disease/case registry
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?
To describe and compare the demographic and clinical features of eosinophilic and non-eosinophilic asthma phenotypes in a cohort of adult patients with severe asthma
To investigate the unique clusters of asthma phenotypes in the international severe asthma registry
Are there primary outcomes?Yes
Description and comparison of demographic and clinical features of the eosinophilic versus non-eosinophilic phenotypes of severe asthma
Are there secondary outcomes?Yes
Unique clusters of severe asthma phenotypes in the international severe asthma registry (ISAR)
13. Study design
What is the design of the study?
Cross-sectional study
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
Firstly, most likely non-eosinophilic asthma patients will be identified followed by discerning eosinophilic asthma patients with most likely vs likely degree of confidence. Descriptive statistics will be provided for continuous and categorical variables accordingly. Summary statistics will be produced for variables measured on the interval or ratio scale, including sample size, mean and SD and categorical variables including range and the percentage by category. A benchmark for each descriptive statistic will be calculated using OPCRD data. Characteristics of groups will be compared via contingency tables and group difference will be tested for statistical significance. Data reduction methods will be used to validate the expected clusters of eosinophilic phenotype and/or to investigate the unique cluster present in the ISAR cohort. Univariate distributions for patient characteristics and clinical characteristics will be described for four identified phenotypes.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
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
