Status: Ongoing
First registered on:
23/10/2014
Last updated on:
24/01/2019
1. Study identification
EU PAS Register NumberEUPAS7744
Official titleThe use of a spacer in the delivery of large (Fluticasone Propionate) and small particle (Qvar®) inhaled corticosteroid (ICS) in asthma
Study title acronymFP and Qvar Spacer vs Non-Spacer in Asthma
Study typeOther: retrospective database study
Brief description of the studyThe objective of this study is to investigate the real life effectiveness of ICS delivery of Fluticasone Propionate (FP) and Qvar® (beclomethasone dipropionate HFA) by pMDI with spacer compared to pMDI alone.
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 groupObservational and Pragmatic Research Institute Pte 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 signed01/03/201401/03/2014
Start date of data collection01/04/201401/04/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTEVA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 1OPRI
Address line 25a Coles Lane
Address line 3
CityCamrbridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)01223967855
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)01223967855
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)R01AD08 (fluticasone)
Product NameQvar
CountryUnited Kingdom
Substance INN(s)BECLOMETASONE DIPROPIONATE
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 subjects18500
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
OPCRD, United Kingdom
Sources of data
This study is a retrospective, effectiveness study consisting of a baseline and outcome period lasting a total of 24 months.This study uses Optimum Patient Care Research Database (OPCRD) which comprises anonymous longitudinal data extracted from approximately 500 UK practices in order to perform reviews of their chronic respiratory services. Data will be supplemented with information from CPRD.
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?
The objective of this study is to investigate the real life effectiveness of ICS delivery of Fluticasone Propionate (FP) and Qvar® (beclomethasone dipropionate HFA) by pMDI with spacer compared to pMDI alone.
Are there primary outcomes?Yes
ATS exacerbations
Are there secondary outcomes?Yes
Clinical exacerbations
Risk domain asthma control
Overall asthma control
Treatment success
SABA use
Hospitalisations
Adherence
Incidence of oral thrush
13. Study design
What is the design of the study?
Retrospective database 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 highlight differences in baseline variable distributions between treatment groups. These differences will be quantified using conditional logistic regression models. Treatment arms will be compared using t-test / Mann Whitney U-test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.
If the exploratory analysis shows significant differences between the cohorts prior to IPD, patients will be matched at IPD for key baseline characteristics; the matching criteria and matching ratio will be determined once the baseline data have been examined. Any residual differences between the treatment arms after matching that are considered to be potentially significant (p<0.10) and any variables predictive of the outcome will be adjusted for through further statistical modelling.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
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
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
