Hidden Severe Asthma in Primary Care versus ISAR Cohort

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33771
• EU PAS number:
  EUPAS28611
• Study ID:
  33771
• Official title and acronym:
  Hidden Severe Asthma in Primary Care versus ISAR Cohort
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To identify, within asthma managed population, patients that have severe asthma but are “hidden” from specialist care using a large, real-life population-based cohort of patients in the UK. Then to compare the demographic and clinical characteristics of the “hidden” patients with severe asthma identified in primary care to those managed in specialist care.Primary objectives:• To construct criteria for identifying severe asthma in primary-care EMR databases based on their treatment and measures of control.• To compare the characteristics of “hidden” patients with severe asthma in primary care to those managed in specialist care (ISAR).Secondary objectives:• To describe the demographic and clinical profile of patients with severe asthma managed exclusively in primary care and are hidden from specialist care.• To describe the demographic and clinical profile of patients treated at low dose ICS/LABA and experiencing exacerbations. These patients may be unrecognised as potentially severe asthma patients.• To create a criteria-template for identifying these patients with severe asthma in other countries
• Study status:
  Finalised

Research institution and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

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

Actual: 20/12/2018

Study start date

Actual: 01/02/2019

Data analysis start date

Planned: 01/03/2019

Actual: 01/03/2019

Date of interim report, if expected

Planned: 27/03/2019

Date of final study report

Planned: 02/09/2019

Actual: 20/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca

Study protocol

Initial protocol

Hidden Severe Asthma Protocol v0.5 060219

Regulatory

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