Comparative Effectiveness of Extra-Fine Particle Inhaled Corticosteroid (ICS) and Alternative Guideline-Recommended Step-Up Options in Pre-School Children

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25899
• EU PAS number:
  EUPAS10684
• Study ID:
  25899
• Official title and acronym:
  Comparative Effectiveness of Extra-Fine Particle Inhaled Corticosteroid (ICS) and Alternative Guideline-Recommended Step-Up Options in Pre-School Children
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This will be a prospectively planned matched cohort study drawing on retrospective, electronic medical records from the Optimum Patient Care Research Database (OPCRD). The small particle size of extra –fine ICS may be particularly relevant for younger, preschool (<5 years) children, in whom a greater proportion of airways are classified as small. The aim of this study is to test the hypothesis that use of EF ICS in pre-school children (i.e. ≤5 years of age) with asthma/wheeze will achieve better outcomes than treatment alternatives (i.e. NEF ICS, LTRA, or SABA) .
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

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: 30/08/2015

Study start date

Planned: 01/09/2015

Actual: 24/09/2015

Data analysis start date

Planned: 09/10/2015

Date of final study report

Planned: 06/05/2016

Sources of funding

Other

More details on funding

REG

Study protocol

Initial protocol

RESEARCH PROTOCOL REG_EF ICS in preschool children_v4

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable