Associations between biological and clinical response following treatment with anti-IL5/5R biologics (FLAME)

Study identification

• EU PAS number:
  EUPAS1000000531
• Study ID:
  1000000531
• Official title and acronym:
  Associations between biological and clinical response following treatment with anti-IL5/5R biologics (FLAME)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Belgium

  Brazil

  Bulgaria

  Canada

  Colombia

  Denmark

  Estonia

  France

  Greece

  India

  Ireland

  Italy

  Japan

  Korea, Republic of

  Kuwait

  Mexico

  Norway

  Poland

  Portugal

  Saudi Arabia

  Singapore

  Spain

  Taiwan

  United Arab Emirates

  United Kingdom

  United States
• Study description:
  A registry-based historical cohort study of severe asthma patients who initiated anti-IL5/5R biologic treatments. Changes in clinical outcomes (lung function and exacerbations) and changes in a biomarker (blood eosinophil count) over time following initiation of the biologic will be related to each other and to baseline patient characteristics as well as to other prior and ongoing asthma treatments. ; The main aim of the study is to identify patient characteristics associated with biological and/or clinical treatment failure at different times after initiation of anti-IL5/5R biologics and the extent to which these are linked or independent events. ; This information will help clinicians in selecting the best treatment for patients and provide important evidence on the information that should be collected before and after biologic initiation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned:17/11/2023

Actual:17/11/2023

Study start date

Planned:15/04/2025

Actual:15/04/2025

Data analysis start date

Planned:15/04/2025

Date of interim report, if expected

Planned:22/12/2025

Date of final study report

Planned:30/06/2026

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Joint funding from AstraZeneca and Optimum Patient Care Global for data collection. Funding from Optimum Patient Care Global for analysis of the data.

Regulatory

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