Real-World Clinical Outcomes in Patients with Severe Asthma Treated with Tezepelumab: A Retrospective Observational Study of CHRONICLE and ISAR (SYNERGY)

Study identification

• EU PAS number:
  EUPAS1000000951
• Study ID:
  1000000951
• Official title and acronym:
  Real-World Clinical Outcomes in Patients with Severe Asthma Treated with Tezepelumab: A Retrospective Observational Study of CHRONICLE and ISAR (SYNERGY)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Brazil

  Canada

  Germany

  Greece

  Hungary

  Italy

  Japan

  Mexico

  Netherlands

  Norway

  Poland

  Saudi Arabia

  Singapore

  Spain

  Switzerland

  United Arab Emirates

  United Kingdom

  United States
• Study description:
  Aim: Assess the real-world effectiveness of tezepelumab in severe asthma across global routine practice, leveraging the CHRONICLE (US) and ISAR registries to characterize use and clinical outcomes in heterogeneous patient populations. ; ; Primary Objective: To describe asthma exacerbations in the 12-month periods before (baseline period) and after the initiation of tezepelumab (study period). ; ; Study Design: This is a multi-country, multi-centre, single-arm, retrospective, observational cohort study in patients with severe asthma who initiated tezepelumab while enrolled in CHRONICLE and ISAR. The index date is the date of first tezepelumab dose. The baseline period is the 12 months prior to the index date, and the study period is the 12 months after the index date. Patients will be followed from their index date until the earliest of the following: end of study (12 months), switching to a different biologic therapy for asthma, death, or lost to follow-up.
• Study status:
  Ongoing

Research institutions and networks

Institutions

AstraZeneca

Study timelines

Date when funding contract was signed

Planned:01/07/2025

Actual:11/07/2025

Study start date

Planned:15/12/2025

Actual:15/12/2025

Data analysis start date

Planned:30/04/2026

Date of final study report

Planned:31/10/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

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