Status: Finalised
First registered on:
11/03/2015
Last updated on:
16/01/2019
1. Study identification
EU PAS Register NumberEUPAS8840
Official titleDose response curves for patients prescribed small & large particle ICS formulation: an observational evaluation of the comparative effect of ICS dose on asthma control achieved in real-life UK patients managed on extrafine hydrofluoroalkane beclomethasone, ciclesonide, fluticasone propionate, or Clenil
Study title acronym
Study typeObservational study
Brief description of the studyAims to evaluate the relationship between ICS dose and treatment outcomes for patients prescribed small or large particle formulation by comparing asthma control outcomes associated with different doses of each ICS in order to create real-life dose-response curves.
The outcomes evaluated are change in severe exacerbation rates, change in percent predicted PEF and change in average daily SABA dose
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 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 signed01/02/2013
Start date of data collection01/04/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report05/11/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 12 Changi Business Park Avenue 1
Address line 2Level 2
Address line 3
CitySingapore
Postcode486015
CountrySingapore
Phone number (incl. country code)6568097251
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 12 Changi Business Park Avenue 1
Address line 2Level 2
Address line 3
CitySingapore
Postcode486015
CountrySingapore
Phone number (incl. country code)6568097251
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Single-Constituent (Substance INN)FLUTICASONE PROPIONATE
Single-Constituent (Substance INN)BECLOMETASONE DIPROPIONATE
Single-Constituent (Substance INN)CICLESONIDE
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 (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects40000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
OPCRD, United Kingdom
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
The aim of the study was to evaluate the relationship between ICS dose and treatment outcomes for patients prescribed small / large particle formulation by comparing asthma control outcomes and treatment-related side effects associated with different doses of each ICS in order to create real-life dose-response curves.
Are there primary outcomes?Yes
Dose-response curves were constructed over the one year outcome period to show patient response to prescribed ICS dose in terms of:
• Increase in severe exacerbations
• Increase in % predicted peak expiratory flow (PEF)
• Increase in average daily SABA use.
Are there secondary outcomes?Yes
Characterise the real-life prescribing of each therapy during the outcome period.
Characterise the real-life consumption of each therapy during 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
Dose response curves (“Characteristics of Response” for initiation cohort) were plotted as error bar plots of:
• Absolute change in severe exacerbation rate (ATS/ERS defined) from baseline to outcome versus ICS dose prescribed at IPD
• Percentage change in severe exacerbation rate (ATS/ERS defined) from baseline to outcome versus ICS dose prescribed at IPD
• Change in percent predicted PEF reading from baseline to outcome versus ICS dose prescribed at IPD
• Change in average daily SABA use from baseline to outcome versus ICS dose prescribed at IPD
The ICS dose prescribed at IPD was categorised as appropriate for the patient sub-group (i.e. dependent on the frequency and spread of prescribed doses). The ICS dose prescribed may be logged.
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
