Study identification

EU PAS number

EUPAS33582

Study ID

40478

Official title and acronym

Impact of Initiating Biologics In Patients on Long-Term OCS Or Frequent Rescue Steroids (GLITTER)

DARWIN EU® study

No

Study countries

Argentina
Bulgaria
Canada
Colombia
Denmark
Germany
Greece
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Mexico
Portugal
Saudi Arabia
Singapore
Spain
Taiwan
United Arab Emirates
United Kingdom
United States

Study description

Data will be sourced from the International Severe Asthma Registry (ISAR). Anonymized person-level data from 19 countries will be used for this analysis. ISAR has governance provided by the ISAR scientific steering committee, The Anonymous Data Ethics Protocols and Transparency (ADEPT) committee, an independent body of experts and regulators commissioned by the Respiratory Effectiveness Group (REG). This is a prospective cohort study in which we will use a propensity score weighting approach to examine the effectiveness of initiating biologic therapy versus continued usual care in severe asthma patients with high SCS use in the real-world settings. The study period is between 2017 and 2019. All study participants will have a history of high SCS use for at least 12 months before entrance into the study. High SCS use refers either to maintenance SCS therapy for at least 1 year or using 4 or more courses of rescue SCS bursts (10 mg/day) for a 12-month period at study entry. We will then divide them into two groups: those who initiated and maintained a biologic therapy (anti-lgE, anti-IL5/anti-IL5R, or anti-IL4R) for ≥6 months (“new biologic users”), and those who stayed on maintenance SCS therapy or used 4 or more courses of SCS bursts (10 mg per day) at time and were also not on any biologic therapy(“high SCS users”). In Phase 1, the demographic and clinical characteristics between the two groups will be compared and studied. In Phase 2, the two study arms will be balanced using propensity score weighting. After which, using weighted longitudinal regression analysis, the two groups will be compared to describe the health outcomes between the groups. These include rate of exacerbations, SCS use, asthma control and incidence of comorbidity.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Respiratory Effectiveness Group (REG)
Belgium
Denmark
France
Germany
Greece
Hungary
Italy
Netherlands
Spain
Sweden
United Kingdom
First published:
04/06/2024
Network
ENCePP partner

Contact details

David Price

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

More details on funding

AstraZeneca, OPC Global
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable