Last updated: 05/31/2024 10:30:26
Impact of Steroid Bursts and High Systemic Corticosteroid (SCS) Exposure on SCS-Related Complications among participants with severe asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Real-World Impact of Steroid Bursts and High Systemic Corticosteroid (SCS) Exposure on SCS-Related Complications among Patients with Severe Asthma in the US
Trial description: This study aims to provide an updated assessment of the association between cumulative SCS exposure and SCS-related complications and the healthcare resource utilization (HRU) due to SCS-related complications in participants with severe asthma.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of SCS and non-SCS user participants with SCS-related complications
Timeframe: Up to 3 months
Secondary outcomes:
Number of SCS and non-SCS user participants with HRU due to SCS-related complications
Timeframe: Up to 3 months
Number of SCS and non-SCS user participants with SCS treatment patterns
Timeframe: Up to 3 months
Number of SCS and non-SCS user participants with biologic treatment patterns
Timeframe: Up to 3 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-25-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Thomas B Casale, Thomas Corbridge, Guillaume Germain, François Laliberté, Sean D MacKnight, Julien Boudreau, Mei S Duh, Arijita Deb. Real-world association between systemic corticosteroid exposure and complications in US patients with severe asthma.. Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology. 2024-03-26;20(1): 25.
DOI : 10.1186/s13223-024-00882-y
PMID: 38532489
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2021 to February 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Inclusion criteria for both SCS Users and SCS Non-Users:
- Greater than or equal to (>=)6 months of continuous eligibility before the index date (Baseline period).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria for both SCS Users and SCS Non-Users:
- Greater than or equal to (>=)6 months of continuous eligibility before the index date (Baseline period).
- Participants with >=12 years of age at the index date. Inclusion criteria for SCS Users:
- >=6 months of continuous use of oral or parenteral SCS with a daily dose equivalent to >=5 milligrams (mg) prednisone. Continuous SCS use defined as no gap greater than (>)14 days between the end of a dispensing/administration (based on days of supply) and the next dispensing/administration, or between the last dispensing/administration and the end of follow-up.
- >=1 dispensing or administration of SCS with a daily dose equivalent to >=5 mg prednisone after the previous six months of continuous SCS use.
- The first dispensing or administration of an SCS medication with a daily dose equivalent to >=5 mg prednisone after the previous six months of continuous SCS use will be defined as the index date.
- >=6 months of continuous eligibility after the index date. The minimum of 2 complete quarters of observation will ensure that all participants will contribute to the study.
- >=2 diagnoses of asthma any time before or on the index date. Inclusion criteria for SCS Non-Users:
- No claim for any oral or parenteral SCS used to treat asthma at any time during their eligibility period, except for those received as part of an outpatient (OP) or Emergency Department (ED) exacerbation. OP/ED exacerbations will be defined as an asthma-related OP visit or asthma-related ED visit with at least one claim for an SCS (intramuscular, intravenous, or oral) within minus (-)4/plus (+)5 days of the encounter. Asthma-related claims will be identified as any claim with a primary diagnosis of asthma.
- >=1 dispensing for a controller or rescue medication for asthma other than SCS. The first dispensing will be defined as the index date for participants with one asthma medication; if multiple asthma medications are initiated (with >=6 months of continuous eligibility beforehand) then the index date will be randomly selected among the initiation dates.
- >=6 months of continuous eligibility after the index date.
- >=2 diagnoses of asthma any time before the index date. Exclusion Criteria for both SCS Users and SCS Non-Users:
- >=1 diagnosis of any cancer of the respiratory and intrathoracic system any time before or on the index date.
- >=1 diagnosis of the following conditions for which Oral corticosteroids (OCS) medications are commonly used to treat any time before or after the index date: Rheumatoid arthritis, Crohn’s disease, Ulcerative colitis, Systemic lupus erythematosus and Multiple sclerosis.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-25-02
Actual study completion date
2022-25-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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