Status: Planned
First registered on:
24/03/2023
Last updated on:
06/11/2023
1. Study identification
EU PAS Register NumberEUPAS104139
Official titleImpact of biologic initiation on steroid burden and new-onset of potentially OCS-related outcomes in patients with severe asthma
Study title acronymSOLAR
Study typeObservational study
Brief description of the study
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
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
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
Australia
Bulgaria
Canada
Colombia
Denmark
Greece
Hungary
India
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Mexico
Poland
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 signed03/10/2022
Start date of data collection02/01/2023
Start date of data analysis
Date of interim report, if expected01/05/2023
Date of final study report31/03/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca60
Charities
Government body
Research councils
EU funding scheme
OtherOPRI Pte Ltd40
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects12814
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
1) To assess the change in OCS intake in the full follow-up period in biologic initiator patients and non-biologic patients.
2) To quantify the association between change in OCS intake and subsequent new onset of potentially OCS-related adverse outcomes all patients, AND/OR
3) To compare the risk of potentially OCS-related adverse outcomes between biologic and non-biologic patients.
Are there primary outcomes?Yes
The total OCS dose at follow-up (which is the sum of long-term OCS dose and rescue steroid dose) will be measured. All three types of OCS dose will be categorized as: increased dose (<0% reduction), low dose reduction (0% to ≤50%), moderate dose reduction (>50% to ≤75%) and optimal dose reduction (>75% to ≤100%). It will also be determined if a patient reached ≤5mg total or long-term OCS dose.
Are there secondary outcomes?Yes
Occurrence of potential OCS related outcomes (Anxiety, Depression, Cerebrovascular accident, Osteoporosis and/or related fractures, Type II diabetes mellitus, progression of diabetes, Cataract/Glaucoma, Obesity (BMI≥30 kg/m3), Peptic Ulcer, Pneumonia, Obstructive Sleep Apnea, Renal Failure, Heart Failure, Myocardial Infarction, Thromboembolism, Pulmonary Embolism) will be determined.
13. Study design
What is the design of the study?
Historic-cohort design
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Descriptive statistics of the baseline (pre-index date) demographic and clinical variables will be conducted and compared for each exposure groups (change in OCS or biologic vs non-biologic groups) as well as by data source (ISAR vs OPCRD). Continuous variables will be summarised using means, standard deviations, medians, ranges and interquartile ranges. Categorical variables will be presented as counts and percentages.
Logistic regression with IPTW-matching will be used to assess the likelihood of attaining low total OCS or LTOCS dose. Low OCS dose will be defined as ≤5mg of total OCS dose or LTOCS.
Univariate and multivariable analyses will be performed for acute and chronic outcomes that are and are not recurrent.
All analyses will be conducted with R version 4.1.0.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
