Effectiveness across severe asthma biologic classes (Anti-IL-5 vs Anti IgE) in patients eligible for both (FIRE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45615
• EU PAS number:
  EUPAS38128
• Study ID:
  45615
• Official title and acronym:
  Effectiveness across severe asthma biologic classes (Anti-IL-5 vs Anti IgE) in patients eligible for both (FIRE)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Bulgaria

  Canada

  Colombia

  Denmark

  Greece

  India

  Ireland

  Italy

  Japan

  Korea, Democratic People's Republic of

  Kuwait

  Mexico

  Saudi Arabia

  Spain

  Taiwan

  United Arab Emirates

  United Kingdom

  United States
• Study description:
  This is a prospective cohort study in which we will use a propensity score weighting approach to examine the effectiveness of initiating Anti-IgE versus Anti-IL5 among patients who are eligible for both modalities. In Phase 1, the demographic and clinical characteristics among all participants who are eligible for both modalities will be studied. These include patients who have an elevated blood eosinophil count, total serum IgE level, 2 or more pre-therapy exacerbation and allergic mediated asthma. In Phase 2, the two study arms will be balanced using propensity score weighting. After this, using weighted longitudinal regression analysis, the two groups will be compared to describe the health outcomes between the groups. These include the rate of exacerbations, OCS use and healthcare resource utilization. Data will be sourced from the International Severe Asthma Registry (ISAR).
• Study status:
  Finalised

Research institutions and networks

Institutions

Optimum Patient Care (OPC)

United Kingdom

Networks

Optimum Patient Care (OPC) Network

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 15/01/2019

Actual: 15/03/2019

Study start date

Planned: 01/11/2019

Actual: 11/11/2019

Data analysis start date

Planned: 01/08/2020

Actual: 01/09/2020

Date of final study report

Planned: 31/12/2021

Actual: 19/01/2022

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca, OPC Global

Study protocol

Initial protocol

ISAR_OPCG1903_Effectiveness across Bx classes_Protocol 13 Aug 2020

Regulatory

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