Increasing ICS Dose vs Add-on Therapy in Children with Asthma (Paediatric Asthma Step-up)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/10484
• EU PAS number:
  EUPAS10483
• Study ID:
  10484
• Official title and acronym:
  Increasing ICS Dose vs Add-on Therapy in Children with Asthma (Paediatric Asthma Step-up)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A historical observational database study UK using primary care data to evaluate the comparative effectiveness of different paediatric asthma step-up options with respect to asthma control at 12 months, specifically ICS dose increase, addition of LABA to existing ICS (as either a separate inhaler or as part of a fixed dose combination) or the addition of LTRA to existing LABA therapy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Research in Real Life

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: 03/12/2012

Actual: 03/12/2012

Study start date

Planned: 07/01/2013

Actual: 07/01/2013

Date of final study report

Planned: 15/07/2015

Actual: 15/07/2015

Sources of funding

Other

More details on funding

Respiratory Effectiveness Group, Research in Real Life Ltd

Study protocol

Initial protocol

GPRD Prescribing Protocol Final Version 2_ENCePP

Regulatory

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