Burden of severe uncontrolled eosinophilic asthma in the UK population

Study identification

• EU PAS number:
  EUPAS10229
• Study ID:
  12824
• Official title and acronym:
  Burden of severe uncontrolled eosinophilic asthma in the UK population
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Background/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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned:03/01/2014

Actual:06/03/2015

Study start date

Planned:06/07/2015

Actual:27/07/2015

Data analysis start date

Planned:26/08/2015

Actual:15/10/2015

Date of interim report, if expected

Planned:25/09/2015

Actual:11/02/2016

Date of final study report

Planned:15/04/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  No