Status: Ongoing First registered on: 09/07/2015
Last updated on: 15/03/2016
1. Study identification
EU PAS Register NumberEUPAS10229
Official titleBurden of severe uncontrolled eosinophilic asthma in the UK population
Study title acronymBurden of severe uncontrolled eosinophilic asthma
Study typeObservational study
Brief description of the studyBackground/Rationale: Benralizumab is a monoclonal antibody against the Interleukine-5 receptor, currently undergoing phase 3 clinical trials for use in the treatment of asthma. This therapy is being developed by AstraZeneca. Benralizumab will target patients with severe, uncontrolled eosinophilic asthma treated with the combination of a high dose of inhaled corticosteroids (ICS) with a long-acting beta2-agonist (LABA). There is a need to establish the proportion of patients with severe uncontrolled eosinophilic asthma among the total population of asthma patients who would be eligible to be treated with benralizumab and to describe their burden of illness and healthcare resource utilisation (HRU). Objectives: The first objective is to describe the distribution of asthma severity, control, treatment status and blood eosinophilia and to establish the proportion of patients with severe uncontrolled eosinophilic asthma among the total population of asthma patients. The second objective will be to assess the rate of exacerbations and HRU during a follow-up year among patients with severe uncontrolled eosinophilic asthma. Study design: Patients with active asthma will be selected from the Clinical Practice Research Datalink (CPRD) and the Optimum Patient Care Research Database (OPCRD). The distribution of asthma severity and control, treatment status, blood eosinophilia, other asthma determinants and their combinations will be described in a baseline year prior to the date of the last blood eosinophil count (index date). Analyses will be performed in patients with and without an overlapping diagnosis of COPD separately. The rate of exacerbations and HRU will be described in the year after the index date in patients with severe uncontrolled eosinophilic asthma, defined as patients with blood eosinophilia, treated with high-dose ICS+LABA, who had ≥2 exacerbations for asthma in the baseline year.
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 belongsOPRI Pte Ltd
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.rirl.org
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 signed03/01/201406/03/2015
Start date of data collection06/07/201527/07/2015
Start date of data analysis26/08/201515/10/2015
Date of interim report, if expected25/09/201511/02/2016
Date of final study report15/04/2016
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 Dr
Last name Marjan
First name Kerkhof
Address line 15a Coles Lane
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)31597856891 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@rirl.org
Public Enquiries
Title Dr 
Last name Marjan 
First name Kerkhof 
Address line 15a Coles Lane 
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)31597856891 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@rirl.org 
Top