Benefits of high dose ICS in patients with asthma and high blood eosinophil counts

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15870
• EU PAS number:
  EUPAS15869
• Study ID:
  15870
• Official title and acronym:
  Benefits of high dose ICS in patients with asthma and high blood eosinophil counts
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A 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.
• Study status:
  Planned

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 30/05/2016

Actual: 30/05/2016

Study start date

Planned: 09/09/2016

Data analysis start date

Planned: 17/10/2016

Date of interim report, if expected

Planned: 03/02/2017

Date of final study report

Planned: 31/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

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