Targeting therapy in people with severe asthma: A retrospective cohort study describing commonly measured biomarkers (eosinophil count and IgE levels) in patients with severe asthma

Study identification

• EU PAS number:
  EUPAS13134
• Study ID:
  26694
• Official title and acronym:
  Targeting therapy in people with severe asthma: A retrospective cohort study describing commonly measured biomarkers (eosinophil count and IgE levels) in patients with severe asthma
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  With the introduction of novel therapies for asthma, it will be useful to differentiate patient need by clinical status (severity) and biomarkers.Patients with severe asthma may be eligible for these potentially life transforming treatments. Biological therapies demonstrate successful outcomes but are (and as new therapies become available, will be) restricted in use by both an assessment of need after optimised care and a biomarker profile consistent with product licenses. Two biomarkers of interest are currently available in routine clinical practice, Blood eosinophil count and total and specific IgE levels. The biological therapy omalizumab may be indicated in patients with severe asthma and an appropriate, raised, IgE. Anti Il-5s (and other therapies) may be indicated in patients with severe asthma and raised blood eosinophil counts. As periostin estimation is not currently in routine use, this biomarker (and its possible guide to Il-13 drug therapy) is not considered in this project.One traditional view is that eosinophil counts and IgE levels are associated. Recent anecdotal evidence proposes that the relationship may not be consistent and that a group of patients who are both eosinophil high and IgE low may exist, for example.By defining the biomarker status of a cohort of people with severe asthma we can estimate the potential impact of precision medicine through appropriate biological therapies for these patients.A preliminary search of the NHS Greater Glasgow and Clyde (NHSGGC) Safe Haven database (n=1.4 million) revealed that about 10,000 IgE levels were requested last year Of these, 1850 were from patients aged 18 years or over who had a Read or ICD code for asthma Study aim: To categorise people with severe asthma according to their eosinophil and total IgE biomarker status.
• Study status:
  Finalised

Research institutions and networks

Institutions

NHSGGC

Study timelines

Date when funding contract was signed

Planned:08/03/2016

Actual:08/03/2016

Study start date

Planned:18/04/2016

Actual:02/05/2016

Data analysis start date

Planned:02/05/2016

Actual:16/05/2016

Date of interim report, if expected

Planned:16/05/2016

Actual:16/05/2016

Date of final study report

Planned:16/05/2016

Actual:27/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva UK

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable