Last updated: 09/19/2025 13:10:18

Comparative effectiveness of Triple Therapy in COPD

GSK study ID
223205
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Effectiveness of Triple Therapy among Medicare Patients with COPD
Trial description: The goal of this study is to compare chronic obstructive pulmonary disorder (COPD) related exacerbations among fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) compared to budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM) initiators with COPD and Medicare Fee-for-Service (FFS) insurance coverage.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Overall COPD related exacerbations

Timeframe: Approximately 36 months

Secondary outcomes:

Time-to-first overall COPD related exacerbations

Timeframe: Approximately 36 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-15-10
Observational study model:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
University of Kentucky
Study date(s)
August 2024 to October 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Greater than or equal to one dispensing of FF/UMEC/VI or BUD/GLY/FORM on or after 1 January 2021
  • a. The first dispensing will define the index date and the study cohort.
  • Less than 40 years of age on the index date
  • Greater than or equal to one SITT dispensing any time prior to the index date to ensure participants are newly initiated on SITT
Inclusion and exclusion criteria
Inclusion criteria:
  • Greater than or equal to one dispensing of FF/UMEC/VI or BUD/GLY/FORM on or after 1 January 2021 a. The first dispensing will define the index date and the study cohort. b. Participants with both FF/UMEC/VI and BUD/GLY/FORM on the index date will not be included in the study.
  • Greater than or equal to 12 months of continuous clinical activity (Medicare FFS analysis) or greater than equal to 12 months of continuous insurance coverage (All insurance plans analysis) prior to the index date a. The 12 month period prior to the index date will be defined as the Baseline period. b. (Medicare FFS analysis) Continuous clinical activity will be defined as consecutive quarters with at least one medical and one pharmacy claims and will be used as a proxy for continuous insurance coverage. c. (All insurance plans analysis) Continuous insurance coverage will be defined based on medical and pharmacy Medicare Advantage, commercial, or Medicaid insurance coverage from the Komodo Research Data (KRD) closed claims database.
  • Greater than or equal to two medical claims with a diagnosis of COPD in any position and in any setting on separate dates of service during the Baseline period or on the index date a. No minimum number of days between distinct dates with a diagnosis of COPD will be required.
Exclusion criteria:
  • Less than 40 years of age on the index date
  • Greater than or equal to one SITT dispensing any time prior to the index date to ensure participants are newly initiated on SITT a. Participants with greater than one SITT dispensing before the start of the Baseline period will be excluded.
  • Dispensing for both FF/UMEC/VI and BUD/GLY/FORM on the index date
  • Greater than or equal to one diagnosis of asthma in any position during the Baseline period
  • Greater than or equal to one diagnosis of cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin in any position during the Baseline period

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2024-15-10
Actual study completion date
2024-15-10

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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