Status: Ongoing First registered on: 03/12/2020
Last updated on: 08/04/2021
1. Study identification
EU PAS Register NumberEUPAS33582
Official titleImpact of Initiating Biologics In Patients on Long-Term OCS Or Frequent Rescue Steroids
Study title acronymGLITTER
Study typeObservational study
Brief description of the studyData 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameOptimum Patient Care Global Limited (OPCG)
Centre locationUK
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
Yes

Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

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
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/01/201915/01/2019
Start date of data collection01/01/201801/01/2018
Start date of data analysis01/08/202015/11/2020
Date of interim report, if expected
Date of final study report01/07/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca50
Charities
Government body
Research councils
EU funding scheme
OtherOPC Global50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15 Coles Lane 
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)44-7787-905057 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
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