Status: Finalised
First registered on:
03/11/2015
Last updated on:
23/10/2018
1. Study identification
EU PAS Register NumberEUPAS11512
Official titleThe role of adherence to inhaled corticosteroids in the relationship between blood eosinophilia and asthma control
Study title acronym
Study typeObservational study
Brief description of the studyPatients with asthma and >0.4x109 blood eosinophils/L are characterized by increased severe exacerbation rates, reduced odds of achieving asthma control and being at higher steps of the GINA guidelines (step 3-4), compared to patients with asthma and lower eosinophil counts (<0.4x109/L).
Alternative therapies that target raised eosinophil counts are being introduced to the market but there is some concern that these treatments will only work for patients with poor adherence to their asthma therapy.
A recent RiRL study found that within the UK, a high proportion of patients at higher GINA steps appear to be adherent to therapy but remain uncontrolled in terms of exacerbations and symptoms. Therefore, there is a need to clarify whether there exists a population of patients with asthma who have persistent elevated blood eosinophil counts, persistent exacerbations and who are adherent to ICS.
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 groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Dr
Last name Khalikulov
First name Bakhtiyor
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 signed01/03/2015
Start date of data collection30/03/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report30/12/201530/12/2015
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 12 Changi Business Park Avenue 1
Address line 2Level 2
Address line 3486015
CitySingapore
Postcode
CountrySingapore
Phone number (incl. country code)6568097251
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name Price
Address line 12 Changi Business Park Avenue 1
Address line 2Level 2
Address line 3486015
CitySingapore
Postcode
CountrySingapore
Phone number (incl. country code)6568097251
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
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 subjects7195
Additional information
1,031 asthma patients with raised eosinophil level; 6,164 asthma patients with normal eosinophil level;
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
iHARP, 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
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To investigate whether poor adherence to ICS therapy explains occurrence of exacerbations or poor asthma control in patients with raised blood eosinophil counts at steps 3 and 4 of the GINA guidelines.
Are there primary outcomes?Yes
Demographic and clinical characteristics of the patients with raised and normal eosinophil levels at steps 3 or 4 of the GINA guidelines.
Are there secondary outcomes?Yes
Patterns of adherence to the ICS treatment in the asthma patients with raised and normal blood eosinophil levels at steps 3 and 4 of the GINA guidelines
13. Study design
What is the design of the study?
Cohort 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
Descriptive statistics of the demographic and clinical characteristics of the patients with raised and normal eosinophil levels at steps 3 or 4 of the GINA guidelines will be produced.
The number (%) of patients with exacerbations (routine, patient-reported and combined variables) and the proportion of patients with controlled asthma (routine and patient-reported variables) will be calculated.
Sensitivity analyses for patients with good treatment adherence (>80%), as well as for lower adherence levels (≤80%) using eosinophils recordings within one year from questionnaire collection and lower cut-off for eosinophil levels (>0.3 x 109/L and ≤0.3 x 109/L) will be performed.
Statistically significant results will be defined as p < 0.05 and trends as 0.05 ≤ p < 0.10.
Differences between groups will be evaluated through Chi-square or Mann-Whitney U tests, as appropriate. Intra-group differences will be evaluated through Chi-square test (p<0.05).
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
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
