Status: Finalised
First registered on:
30/09/2013
Last updated on:
17/03/2015
1. Study identification
EU PAS Register NumberEUPAS4872
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 1
Study title acronymReal-life effectiveness of Flutiform® Phase 1
Study typeObservational study
Brief description of the study
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 group
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 collection01/09/201201/08/2013
Start date of data analysis01/11/201301/11/2013
Date of interim report, if expected
Date of final study report31/01/201431/01/2014
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
OtherResesarch in Real Life50
5. Contact details for enquiries
Scientific 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)44-1223967855
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)44-1223967855
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameFlutiform
CountryUnited Kingdom
Substance INN(s)FLUTICASONE PROPIONATE
FORMOTEROL
Product NameSeretide
CountryUnited Kingdom
Substance INN(s)FLUTICASONE PROPIONATE
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
9. Number of subjects
Estimated total number of subjects100
Additional information
A minimum of 100 Flutiform patients for change success analysis
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
Routine patient questionaires
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 evaluate the success 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
In this Phase 1 study, change success will be evaluated. Change success is defined as Percentage of FP/FOR patients who received ≥2 prescriptions of FP/FOR (i.e. ≥1 prescription in addition to that issued at IPD).
Are there secondary outcomes?Yes
If failed, the potential reasons for discontinuation will be evaluated including:
(i) Occurrence of severe exacerbations within the 6-month period defined as:
(ii) Loss of asthma control (in the subset of patients controlled at baseline) (iii) Adverse events
13. Study design
What is the design of the study?
Retrospective 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
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 19 [89], SAS version 9.3 [910] and Microsoft Office EXCEL 2007.
Summary statistics
Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by treatment groups. 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
1. Masoli M, Fabian D, Holt S, Beasley R: Global burden of asthma, a report for the Global Initiative for Asthma. 2004.http://www.ginasthma.org
2. Bahadori K, Doyle-Waters M, Marra C, Lynd L, Alasaly K, Swiston J, FitzGerald JM: Economic burden of asthma: a systematic review.BMC Pulm Med 2009, 9:24.
3. Demoly P, Gueron B, Annunziata K, Adamek L, Walters RD: Update on asthma control in five European countries: results of a 2008 survey. Eur Respir Rev 2010, 19:150-157.
5. Politiek MJ, Boorsma M, Aalbers R: Comparison of formoterol, salbutamol and salmeterol in methacholine-induced severe bronchoconstriction. Eur Respir J 1999, 13:988-992.
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
