Status: Planned First registered on: 18/10/2016
Last updated on: 18/10/2016
1. Study identification
EU PAS Register NumberEUPAS15869
Official titleBenefits of high dose ICS in patients with asthma and high blood eosinophil counts
Study title acronym
Study typeObservational study
Brief description of the studyA previous study conducted by the Observational and Pragmatic Research Institute (OPRI) found that patients with asthma and high blood eosinophil counts experience more severe exacerbations and have poorer asthma control. The results suggest that this subpopulation of patients with asthma does not respond well to guideline-recommended therapy. There is no evidence available that a step-up to high dose ICS would be effective in preventing asthma attacks in these patients. Nevertheless, high ICS doses are frequently prescribed in real-life, exposing patients to the risk of adverse effects. The objective is to study the effectiveness of initiating patients with high blood eosinophil counts on high dose ICS to reduce exacerbation risk and to achieve asthma control. Patients with asthma and high blood eosinophil counts who step-up to high dose ICS will be extracted from the Clinical Practice Research Datalink or the Optimum Patient Care Research Database (date is index date (ID)). Patients who step-up from medium to high dose ICS will be matched to and compared with control patients on stable medium dose treatment during follow-up. The ID of control patients will be chosen at exactly the same number of days after the date of blood eosinophil count recording as the matched step-up patient. Patients who step up from low to high dose ICS will be matched to and compared with patients who step up from low to medium dose ICS. Patients will be matched on the following characteristics assessed in the year prior to ID: timing and value of eosinophil count, number of exacerbations, ICS drug and dose, propensity score of high dose ICS assignment. Survival and negative binomial regression analyses will be used to compare the rates of asthma exacerbations over 1 and 3 years of follow-up.
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 applicableNot applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOPRI Pte Ltd
Department/Research groupOPRI
Organisation/affiliationOPRI Pte Ltd
Website/Homepagehttp://opri.sg
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 signed30/05/201630/05/2016
Start date of data collection09/09/2016
Start date of data analysis17/10/2016
Date of interim report, if expected03/02/2017
Date of final study report31/03/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
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 15a Coles Lane
Address line 2Oakington 
Address line 3 
CityCambridge 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg 
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