The healthcare costs associated with comorbidities of refractory asthma and systemic steroid exposure in the UK (Refractory Asthma & Steroid Exposure)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/5033
• EU PAS number:
  EUPAS5032
• Study ID:
  5033
• Official title and acronym:
  The healthcare costs associated with comorbidities of refractory asthma and systemic steroid exposure in the UK (Refractory Asthma & Steroid Exposure)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study will use the UK’s Optimum Patient Care Research Database (OPCRD) to address a number of objectives relating to refractory asthma in the UK. The findings of the OPCRD evaluations will be compared to those of the British Thoracic Society's Difficult Asthma Registry morbidity prevalence data to help provide best morbidity prevalence estimates for the UK’s refractory asthma populations and to inform the development of models to estimate the burden of steroid-induced morbidity.The study will consist of two key phases:Phase 1: a cross-sectional matched cohort comparison of morbidity rates in patients with refractory asthma, those with well-controlled asthma and in non-asthmatic controls.Phase 2: a 7-year longitudinal matched cohort comparison of new incidence of morbidities in patients with refractory asthma, well-controlled asthma and non-asthmatic controls.
• Study status:
  Ongoing

Research institution and networks

Institutions

Queen's University Belfast

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 19/08/2013

Actual: 19/08/2013

Study start date

Planned: 02/09/2013

Actual: 02/09/2013

Date of final study report

Planned: 01/04/2014

Sources of funding

Other

More details on funding

University, Respiratory Effectiveness Group

Study protocol

Initial protocol

Refractory Asthma and oral steroid use_OPCRD study protocol_final281013

Regulatory

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