Status: Ongoing
First registered on:
25/03/2015
Last updated on:
23/10/2018
1. Study identification
EU PAS Register NumberEUPAS9105
Official titleReal-world effectiveness of extra-fine formulations in Denmark
Study title acronym
Study typeObservational study
Brief description of the studyA retrospective effectiveness analysis comparing extra-fine inhaled corticosteroid formulations with non extra-fine inhaled corticosteroid formulations in the real-world management of patients with asthma in Denmark
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
Multiple centres
In total how many centres are involved in this Study?2
Forskningsenheden for Almen Praksis, IST, Syddansk Universitet
Countries in which this study is being conducted
National study
Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/12/201307/05/2014
Start date of data collection02/04/201430/06/2014
Start date of data analysis14/07/201419/08/2014
Date of interim report, if expected10/12/201426/09/2014
Date of final study report30/06/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva50
CharitiesRiRL50
Government body
Research councils
EU funding scheme
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)441223967855
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)441223967855
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameSalbutamol Sterinebs
CountryUnited Kingdom
Substance INN(s)SALBUTAMOL
Product NameVentolin Nebules
CountryUnited Kingdom
Substance INN(s)SALBUTAMOL
7. Medical conditions to be studied
Medical condition(s)Yes
Chronic obstructive pulmonary disease
8. Population under study
Age
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 subjects9273
Additional information
1335 individuals in the Salbutamol Sterinebs treatment group and 7938 individuals in the Ventolin Nebules treatment group.
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
Optimum Patient Care research Database, United Kingdom
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Risk assessment
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
The aim of this study is to compare Salbutamol SteriNebs® with its originator, Ventolin Nebules®. The primary objective is to assess whether effectiveness of Salbutamol SteriNebs® is non-inferior to that of Ventolin Nebules®.
Are there primary outcomes?Yes
Primary outcome of this study is “effectiveness”, evaluated in terms of:
(1) Severe COPD exacerbations (hospitalisations) in the outcome period, and
(2) Moderate and severe COPD exacerbations in the outcome period.
Please see the attached protocol for full definitions of these outcomes
Are there secondary outcomes?Yes
Secondary outcome of this study is “safety”, evaluated in terms of Adverse Events (AEs). These will include AEs known to be related to Salbutamol SteriNebs® and Ventolin Nebules®, as specified in their respective summary of product characteristics. Please see the attached protocol for a fuller definition of this outcome.
13. Study design
What is the design of the study?
Cohort study
Historical cohort 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
Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10
Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by therapy. Treatment groups 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.
Outcomes analyses: patients may be matched on demographics and key measures of disease severity to minimise confounding, using random selection process through SAS statistical software to avoid selection bias.
Effectiveness and safety outcomes in the outcome period will be compared between treatment groups using a Conditional Poisson regression model. The model will use empirical standard errors (for more conservative confidence interval estimations) and adjustments will be made for potential baseline confounders. The adjusted rate ratio with 95% confidence interval will be reported.
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
