Status: Finalised
First registered on:
26/05/2016
Last updated on:
26/01/2017
1. Study identification
EU PAS Register NumberEUPAS13586
Official titleDoes the cost of inhaler devices affect therapy adherence and disease outcomes?
Study title acronym
Study typeObservational study
Brief description of the studyThe aim of the study is to investigate whether a raise in prescription costs affects maintenance therapy and disease outcomes in patients with asthma or COPD. The objectives are to characterise patients who pay prescription charges and those who do not (i.e. HSE medical card holders) in an Irish primary care population diagnosed with asthma or COPD and for both groups to assess whether maintenance therapy adherence and disease control is better in patients who do not pay prescription charges compared to those who do pay.
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 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 signed09/06/201609/06/2016
Start date of data collection17/06/201604/11/2016
Start date of data analysis29/07/201604/11/2016
Date of interim report, if expected15/08/201611/11/2006
Date of final study report01/11/201623/11/2016
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
OtherRIRL50
DASG50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Voorham
First name Jaco
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 Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441223967582
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
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects150
Additional information
77 patients per treatment group (patients having free prescriptions, patients paying for prescriptions, 1:1)
10. Source of data
Is this study being carried out with an established data source?No
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?
To find if free prescriptions influences adherence to asthma and COPD treatment
Are there primary outcomes?Yes
Adherence to maintenance asthma and COPD therapy
Are there secondary outcomes?Yes
Risk domain asthma control
Number of severe exacerbations
Acute respiratory events
SABA reliever usage
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
Baseline differences across the study cohorts will be analysed to look for differences
The proportion of patients who are considered adherent (>80% refill rate) will be compared between the free prescription and the paying group. A difference of 25% will be considered significant.
Secondary outcomes will be compared using chi square and wilcoxon tests as appropriate.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
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
