Status: Planned
First registered on:
18/04/2016
Last updated on:
18/04/2016
1. Study identification
EU PAS Register NumberEUPAS13185
Official titleInhaled Corticosteroid and Real Life unlicensed Spacer Use (stage 1)
Study title acronymICARUS 1
Study typeObservational study
Brief description of the studyExamining the real-life unlicensed and licensed use of inhaled corticosteroids with or without spacers in patients with asthma in the United Kingdom
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
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?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/04/2016
Start date of data collection09/05/2016
Start date of data analysis10/05/2016
Date of interim report, if expected06/06/2016
Date of final study report31/08/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companieschiesi100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Wan Yau Ming
First name Simon
Address line 15a Coles lane
Address line 2
Address line 3
CityOakington
Postcode
CountryUnited Kingdom
Phone number (incl. country code)01223967827
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Mr
Last name Wan Yau Ming
First name Simon
Address line 15a Coles lane
Address line 2
Address line 3
CityOakington
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441223967827
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Single-Constituent (Substance INN)BECLOMETASONE PROPIONATE
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects20000
Additional information
Approximately 20 000 patients explored to be categorised into patients treated with different spacers and non extra fine beclomethasone
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
An exploratory study into the numbers of patients prescribed spacers with non extra fine beclomethasone for asthma in the UK
Are there primary outcomes?Yes
Exploratory study into patient numbers using spacers in asthma with non extra fine beclomethasone
Are there secondary outcomes?No
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
The number and proportion of patients taking each spacer will be split by demographic characteristics and these will be presented in the final report
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
