Status: Ongoing
First registered on:
18/04/2016
Last updated on:
13/02/2017
1. Study identification
EU PAS Register NumberEUPAS13194
Official titleICARUS: Inhaled Corticosteroid And Real life Unlicensed Spacer use – stage 2
Study title acronymICARUS 2
Study typeObservational study
Brief description of the studyExamining the real-life unlicensed and licensed use of inhaled corticosteroids with spacers in patients with asthma in the United Kingdom comparing non extra fine beclomethasone in Aerochamber and Volumatic spacers
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 groupOPRI
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 signed18/04/201627/10/2016
Start date of data collection03/01/201703/01/2017
Start date of data analysis04/01/201704/01/2017
Date of interim report, if expected17/02/2017
Date of final study report24/02/2017
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)441223967827
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
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 subjects200
Additional information
Patients have asthma outcome questionairres and will be matched one to one for patients prescribed with Aerochamber and Volumatic spacers
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?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To compare the number of inhaled corticosteroid related adverse events in patients prescribed aerochamber and volumatic spacers and non extra fine beclomethasone
Are there primary outcomes?Yes
This is the number of adverse events by questionairre namely reported occurence of oral thrush OR hoarseness
Are there secondary outcomes?Yes
These are database outcomes including evidence of osteoporosis, rash, swelling, glaucoma and adrenal failure in the outcome period
13. Study design
What is the design of the study?
Cohort 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 two groups will be compared for the number of adverse events using a Poisson regression model. Non inferiority will be achieved if the proportion of Aerochamber/beclomethasone adverse events (defined by oral thrush or hoarseness) is no more than 13% higher than volumatic/beclomethasone adverse events in the questionnaire returns
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
