Status: Finalised
First registered on:
03/02/2016
Last updated on:
11/07/2017
1. Study identification
EU PAS Register NumberEUPAS12275
Official titleReal-life effectiveness evaluation of asthma treatment in Korea
Study title acronymTransfform
Study typeObservational study
Brief description of the studyA historical, observational study to evaluate the real-life effectiveness and cost-effectiveness of asthma treatment in the HIRA Database of Korea specifically examining the switch from the use of dry powder to pressurised metered dose inhalers.
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
Korea, Republic of
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/02/201615/04/2016
Start date of data collection31/03/201616/09/2016
Start date of data analysis29/04/201623/09/2016
Date of interim report, if expected01/11/201631/01/2017
Date of final study report02/01/201711/07/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMundipharma Asia50
Charities
Government body
Research councils
EU funding scheme
OtherRIRL50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Yau
First name Simon
Address line 15a Coles Lane
Address line 2
Address line 3
CityOakington
Postcode
CountryUnited Kingdom
Phone number (incl. country code)44-1223-967830
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Yau
First name Simon
Address line 15a Coles Lane
Address line 2
Address line 3
CityOakington
Postcode
CountryUnited Kingdom
Phone number (incl. country code)44-1223-967830
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Multi-Constituent (Substance INN(s))BUDESONIDE, MICRONISED
FORMOTEROL FUMARATE
FLUTICASONE PROPIONATE
FLUTICASONE FUROATE
SALMETEROL XINAFOATE
BECLOMETASONE DIPROPIONATE MONOHYDRATE
BECLOMETASONE DIPROPIONATE
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 subjects2000
Additional information
Suspected to be 1000 patients that switch from DPI to MDI, compared to 1000 matched patients who remain on DPIs
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Administrative database, e.g. claims database
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?
To assess asthma outcomes in patients who switch from DPI to pMDI devices and who continue with DPI devices in Korea.
Are there primary outcomes?Yes
Switch persistance, defined as:
Percentage of ICS/LABA pMDI patients who received ≥ 3 prescriptions of ICS/LABA pMDI in addition to that issued at their prescription date at 6 months
Are there secondary outcomes?Yes
(a) % non-exacerbating patients of ‘switch’ cohort at 1 year, compared to baseline
% of ‘switch’ cohort who have no severe exacerbations within 1 year of switching at 1 year, compared to year before switching
(b) Severe asthma exacerbation rate (American Thoracic Society/European Respiratory Society statement definition) within the 1 year 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
Summary statistics will be produced for all baseline variables. The baseline variables for the two cohorts will be compared using the following tests:
• Variables measured on the interval/ratio scale:
− t-test (normal distribution)
− Mann-Whitney U test (skewed data)
• Categorical variables:
− Chi-square test
Results will be reported as:
• Variables measured on the interval/ratio scale:
− Sample size (n) and percentage non-missing
− Median and inter-quartile range (25th and 75th percentiles)
• Categorical variables:
− Sample size (n)
− Count and percentage by category (distribution)
Based on an expected “switch-back” probability of approximately 0.20 (20%) among patients switching from existing ICS/LABA DPI to ICS/LABA pMDI at their prescription date, a sample size of 100 patients per switch cohort would be sufficient to construct a 95% one-sided confidence interval with an upper bound of less than 0.30 (30%) to power the evaluation of ICS/LABA pMDI “switch success”
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
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
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
