Status: Finalised
First registered on:
09/10/2014
Last updated on:
17/03/2015
1. Study identification
EU PAS Register NumberEUPAS7641
Official titleReal-life effectiveness (and cost impact) evaluation of fixed-dose combination fluticasone propionate/formoterol (Flutiform®) for the management of asthma in a routine UK primary care population – Phase 2
Study title acronymReal-life effectiveness of Flutiform - Phase 2
Study typeObservational study
Brief description of the studyTo evaluate the comparative effectiveness of changing real-life asthma patients from fluticasone propionate / salmeterol (Seretide®; FP/SAL) to fluticasone propionate / formoterol (Flutiform®; FP/FOR) in asthma patients.
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
Centre to which the investigator belongsRIRL
Department/Research groupDatabase research department
Organisation/affiliationResearch in Real Life Ltd.
Details of (Primary) lead investigator
Title Dr
Last name Lim
First name Daina
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 signed25/07/201225/07/2012
Start date of data collection03/02/201403/02/2014
Start date of data analysis18/08/201401/11/2014
Date of interim report, if expected
Date of final study report28/11/201431/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNapp Pharmaceuticals50
Charities
Government body
Research councils
EU funding scheme
OtherRIRL50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Daina
First name Lim
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-1223-967876
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 1University of Aberdeen
Address line 2
Address line 3
CityAberdeen
PostcodeAB24 3FX
CountryUnited Kingdom
Phone number (incl. country code)44-1223-967855
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameSeretide
CountryUnited Kingdom
Substance INN(s)FLUTICASONE PROPIONATE
SALMETEROL
Product NameFlutiform
CountryUnited Kingdom
Substance INN(s)FLUTICASONE PROPIONATE
FORMOTEROL
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 subjects154
10. Source of data
Is this study being carried out with an established data source?Yes
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?
Disease epidemiology
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To evaluate the comparative effectiveness of changing real-life asthma patients from fluticasone propionate / salmeterol (Seretide®; FP/SAL) to fluticasone propionate / formoterol (Flutiform®; FP/FOR).
Are there primary outcomes?Yes
Co-primary outcomes
1. Severe exacerbation rate (ATS definition)
Defined as any of the following (outcome year):
• Asthma-related hospital or emergency room attendance
• Acute oral steroid prescriptions for asthma
2. Composite proxy asthma control
Defined as absence of the following (outcome year):
• Severe exacerbations
• Antibiotics prescriptions for LRTIs at a respiratory consultation
Are there secondary outcomes?Yes
Secondary outcomes:
1. ICS use – mean daily ICS dose
2. Short-acting beta2agonist (SABA) use – mean daily SABA dose
Cost impact outcomes (optional)
1. Asthma drug costs ± FDC ICS/LABA drug costs
2. Cost of asthma resource utilisation
3. Cost of asthma-related resource utilisation
13. Study design
What is the design of the study?
Cross-sectional study
historical
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
General Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10. All analyses will be carried out using SPSS version 22 and Microsoft Office EXCEL 2013. Summary statistics Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and for both baseline and outcome period. For variables measured on the interval or ratio scale, these will include: • Sample size (n) • Percentage non-missing • Mean • Variance / Standard Deviation • Range (Minimum / Maximum) • Median • Inter-quartile Range (25th and 75th percentiles) For categorical variables, the summary statistics will include: • Sample size (n) • Range (if applicable) • Count and Percentage by category (distribution)
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
6. Politiek MJ, Boorsma M, Aalbers R: Comparison of formoterol, salbutamol and salmeterol in methacholine-induced severe bronchoconstriction. Eur Respir J 1999, 13:988-992.
9. Mueller-Waltz R et al. Respiratory Drug Delivery Europe 2011; Book 2 pp 431-434.
10. Venthoye et al. Respiratory Drug Delivery Europe 2011; Book 2 pp 435-438.
11. Bodzenta-Lukaszyk A, Dymek A, McAulay K, Mansikka H: Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med 2011, 11:28.
12. Aalbers R, Brusselle G, McIver T, Grothe B, Bodzenta-Lukaszyk A: Onset of bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomized study. Adv Ther 2012, 29:958-69.
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
