Last updated: 02/16/2024 14:20:12
Effect of TRELEGY® on Oral corticosteroids (OCS) use in chronic obstructive pulmonary disease (COPD)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Changes in OCS use and Healthcare Resource Use and Costs in Patients with COPD Following Initiation of Trelegy
Trial description: This non-interventional retrospective study will analyze participants with COPD initiating TRELEGY identified in the MarketScan® Commercial and Medicare Supplemental Databases. The aim of the study is to describe changes in OCS use, prevalence of OCS-related adverse events (AEs) and all-cause and COPD-related healthcare resource use and costs following initiation of treatment with TRELEGY. TRELEGY is a registered trademark of GlaxoSmithKline group of companies. MARKETSCAN is a registered trademark of Truven Health Analytics Inc.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with any pharmacy claims for OCS
Timeframe: Up to 12 months
Mean number of OCS pharmacy claims per participant
Timeframe: Up to 12 months
Number of participants with chronic OCS use
Timeframe: Up to 12 months
Mean prednisone equivalent daily dose of OCS
Timeframe: Up to 12 months
Number of participants with OCS bursts
Timeframe: Up to 12 months
Percentage of days covered
Timeframe: Up to 12 months
Change from Baseline in mean daily dose
Timeframe: Baseline and up to 12 months
Secondary outcomes:
Number of participants with OCS-related AEs
Timeframe: Up to 12 months
Number of participants with all-cause and COPD-related healthcare resource use
Timeframe: Up to 12 months
Total cost associated with all cause and COPD-related healthcare use
Timeframe: Up to 12 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-01-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Abbott C, Bangalore M, Bogart M, DiRocco K, McMorrow D, Packnett E, et al. . Changes in oral corticosteroid utilization in patients with COPD following initiation of FF/UMEC/VI. Int J Chron Obstruct Pulmon Dis.
DOI: 10.2147/COPD.S419272
PMID: 37933243
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
January 2021 to November 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- More than or equal to (>=)1 inpatient claim with a diagnosis of COPD in the primary position or >=2 non-diagnostic outpatient claims with a diagnosis of COPD with different service dates between 01-Nov-2017 and 31-Dec-2018 in the MARKETSCAN Commercial or Medicare Supplemental Databases. The diagnosis date will be the date of the first COPD diagnosis.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- More than or equal to (>=)1 inpatient claim with a diagnosis of COPD in the primary position or >=2 non-diagnostic outpatient claims with a diagnosis of COPD with different service dates between 01-Nov-2017 and 31-Dec-2018 in the MARKETSCAN Commercial or Medicare Supplemental Databases. The diagnosis date will be the date of the first COPD diagnosis.
- >=40 years old on the COPD diagnosis date.
- >=12 months’ continuous enrollment prior to and following the COPD diagnosis date.
- >=1 OCS pharmacy claim in the 12 months prior to the COPD diagnosis date.
- >=1 pharmacy claim for TRELEGY following the date of first COPD diagnosis. The index date will be the date of the first TRELEGY prescription and will be considered as part of the Baseline period.
- >=12 months’ continuous enrollment prior to the index date (Baseline period) and following the index date (follow-up period). Exclusion criteria:
- Not applicable.
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
2021-01-11
Actual study completion date
2021-01-11
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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