ENLIGHTEN: Assessment of quality improvement in the International Severe Asthma Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000510
• EU PAS number:
  EUPAS1000000510
• Study ID:
  1000000510
• Official title and acronym:
  ENLIGHTEN: Assessment of quality improvement in the International Severe Asthma Registry
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Belgium

  Brazil

  Bulgaria

  Canada

  Colombia

  Denmark

  Estonia

  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 prospective cohort study using data on eligible adults with severe asthma in ISAR (International Severe Asthma Registry). We will investigate how data quality and clinical practice in ISAR has changed over time using a combination of joinpoint regression, interrupted time-series and time-to-event analyses.
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned: 11/11/2023

Study start date

Planned: 01/02/2025

Data analysis start date

Planned: 01/02/2025

Date of interim report, if expected

Planned: 22/12/2025

Date of final study report

Planned: 15/12/2026

Sources of funding

Other

More details on funding

Joint funding from AstraZeneca and Optimum Patient Care Global

Study protocol

Initial protocol

ENLIGHTEN_Protocol_Final_25.02.05_clean.pdf

Regulatory

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