Status: Finalised
First registered on:
02/03/2016
Last updated on:
02/03/2016
1. Study identification
EU PAS Register NumberEUPAS12631
Official titleReal life effectiveness and cost impact evaluation of fixed dose combination fluticasone propionate/formoterol (Flutiform®) compared to fluticasone propionate/salmeterol (Seretide®)
Study title acronymeFFectiveness
Study typeObservational study
Brief description of the studyThis study examines the effectiveness and cost impact of treatment with an inhaled corticosteroid/long acting beta agonist (ICS/LABA) either as fluticasone propionate/formoterol (FP/FOR) or fluticasone propionate/salmeterol (FP/SAL) in asthmatic patients extracted from the optimum patient care database (OPCD).
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 signed01/01/201430/03/2014
Start date of data collection02/03/201502/03/2016
Start date of data analysis03/08/201524/08/2015
Date of interim report, if expected17/03/201601/03/2016
Date of final study report29/04/201602/03/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNapp50
Charities
Government body
Research councils
EU funding scheme
OtherRIRL50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Wan Yau Ming
First name Simon
Address line 15a Coles Lane
Address line 2
Address line 3
CityOakington
PostcodeCB243BA
CountryUnited Kingdom
Phone number (incl. country code)441223967830
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
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)4408082800792
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Multi-Constituent (Substance INN(s))FLUTICASONE PROPIONATE
FORMOTEROL
SALMETEROL
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
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 subjects43504
Additional information
42851 patients in combined control group (FP/SAL) subdivided into 17365 in the change subcohort and 25486 in the initiation subcohort
653 patients in combined comparator group (FP/FOR) subdivided into 468 in the change cohort and 185 in the initiation cohort
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?
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To examine non-inferiority of effectiveness (in terms of ‘no exacerbations’ [ATS/ERS Task Force definition]) of fluticasone propionate / formoterol (Flutiform®; FP/FOR) relative to fluticasone propionate / salmeterol (Seretide®; FP/SAL) in matched patients from two cohorts of patients with asthma
Are there primary outcomes?Yes
To evaluate whether asthma patients treated with FP/FOR are associated with a non-inferior proportion with no exacerbations when compared to asthma patients treated with FP/SAL
Are there secondary outcomes?Yes
To evaluate comparative effectiveness and cost impact outcomes of fluticasone propionate / formoterol (Flutiform®; FP/FOR) relative to fluticasone propionate / salmeterol (Seretide®; FP/SAL) in matched patients from two cohorts of patients with asthma
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
Patients will be combined from two cohorts - those who initiated on a fixed dose combination ICS/LABA and those who change to FP/FOR or continue on FP/SAL. Patients will be matched on one year of baseline characteristics including age, gender, spirometry, exacerbations, rhinitis, smoking status and predicted peak flow. After matching, adjusted analysis was provided for the primary outcome (proportion of patients with no exacerbations). A difference of less than 3.5% of the lower 95% confidence interval between the comparator (FP/FLU) and the control (FP/SAL) was considered to be non-inferior. Additional secondary outcomes are compared as appropriate using odds ratios, rate ratios and conditional logistic regression. Cost impact was compared through assessment of lower respiratory related medication, lower respiratory resource use and the combined medication and resource use after matching.
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
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
