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

Networks

Respiratory Effectiveness Group (REG)
Belgium
Denmark
France
Germany
Greece
Hungary
Italy
Netherlands
Spain
Sweden
United Kingdom
First published:
08/07/2021
Network
ENCePP partner

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca
Study protocol
Initial protocol
English (360.57 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable