Status: Finalised
First registered on:
19/05/2014
Last updated on:
17/03/2015
1. Study identification
EU PAS Register NumberEUPAS6573
Official titleReal-life effectiveness evaluation of the long-acting muscarinic antagonist aclidinium bromide (Eklira®) for the management of COPD in a routine UK primary care population - Study 1
Study title acronymReal-life acceptability of Eklira
Study typeObservational study
Brief description of the studyTo evaluate the real-life effectiveness of the antimuscarine bronchodilator aclidinium bromide (Eklira®) in three combined studies following the launch of Eklira® in the UK. This first study involves characterising patients prescribed aclidinium bromide from tiotropium, and determining how many patients are satisfied with their change to aclidinium therapy. This will determine the acceptability of aclidinium in clinical practice.
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 Daina
First name Lim
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 signed26/09/201326/09/2013
Start date of data collection01/10/201301/10/2013
Start date of data analysis02/06/201413/05/2014
Date of interim report, if expected
Date of final study report29/08/201406/10/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAlmirall50
Charities
Government body
Research councils
EU funding scheme
OtherResearch 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)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 NameEklira
CountryUnited Kingdom
Substance INN(s)ACLIDINIUM BROMIDE
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 subjects100
Additional information
100 of patients on Eklira meeting the selection criteria. Based on a 20% switch back rate among the patients, to construct a 95% one-sided confidence interval with an upper bound of less than 0.30 (30%) to power the evaluation of Eklira acceptabilty.
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
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Drug utilisation study
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To evaluate the real-life effectiveness of the antimuscarine bronchodilator aclidinium bromide (Eklira®) as part of a three-staged study following the launch of Eklira® in the UK. This first study involves characterising patients prescribed aclidinium bromide from tiotropium and determine the acceptabily of aclidinium by determining how many patients are satisfied with their change to aclidinium.
Are there primary outcomes?Yes
The primary outcome for this study is the acceptability of change from tiotropium to aclidinium during the six-month outcome period.
This is defined as the percentage of the patients changed to aclidinium bromide (received a prescription for aclidinium at date of first prescription) who did not receive ≥1 prescription for tiotropium during the outcome period.
Are there secondary outcomes?Yes
To provide real-world data on the utilisation of aclidinium bromide in clinical practice, the patients prescribed aclidinium bromide will be characterised following in the year prior to aclidinium bromide initiation. As the study aims to characterise the patients who are prescribed aclidinium, all patients will be characterised regardless of whether or not they change back to tiotropium.
13. Study design
What is the design of the study?
Drug utilisation 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 be produced for all baseline variables.
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)
• Count and Percentage by category (distribution).
Plots will be produced for all baseline variables.
For variables measured on the interval or ratio scale, these will include:
• Frequency plots
• Box and whisker plots
The data will be prepared for analysis by:
• Investigating potential outliers;
• Indentifying and creating new variables as necessary:
o Transformations of skewed data (for example, log transformations);
o Categorisation of heavily skewed data;
• Investigating missing data (type of and reason for missingness).
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
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: Development and Validation. J Chronic Dis 1987;40:373-383.
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
