Last updated: 06/24/2026 12:30:25
Comparative outcome of single-inhaler triple therapies (SITT) in participants with chronic obstructive pulmonary disease (COPD)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Comparative Outcomes of New Users of FF/UMEC/VI vs BUD/GLY/FORM Initiated for Real World Management of COPD
Trial description: The goal of the study is to compare the rate and risk of COPD exacerbations and all-cause mortality between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) and Budesonide/Glycopyrrolate/Formoterol (BUD/GLY/FORM) initiators in participants with Medicare Fee-for-Service insurance who used dual therapy (i.e., inhaled corticosteroid [ICS]/long-acting beta2-agonists [LABA] or long-acting muscarinic antagonists[LAMA]/LABA) as their latest treatment before SITT (SITT initiation, as well as those who used dual therapy and had presence of zero, one or more, or two or more COPD exacerbations before SITT initiation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with exacerbation per year
Timeframe: Up to approximately 36 months
Secondary outcomes:
Time-to-first exacerbation
Timeframe: Up to approximately 36 months
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2025-31-12
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma, Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Analysis Group
Study date(s)
March 2025 to December 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Greater than or equal to (>=) 1 dispensing of FF/UMEC/VI or BUD/GLY/FORM on or after January 1, 2021.
- Greater than or equal to (>=) 2 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.
- Greater than or equal to (>=) 1 SITT dispensing any time prior to the index date to ensure participants are newly initiated on SITT.
- Greater than or equal to (>=) 1 diagnosis of asthma, cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin in any position during the Baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
- Greater than or equal to (>=) 2 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.
Greater than or equal to (>=) 1 dispensing of FF/UMEC/VI or BUD/GLY/FORM on or after January 1, 2021.
Exclusion criteria:
- Greater than or equal to (>=) 1 diagnosis of asthma, cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin in any position during the Baseline period.
Greater than or equal to (>=) 1 SITT dispensing any time prior to the index date to ensure participants are newly initiated on SITT.
Trial location(s)
No location data available.
Study documents
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
Finalized
Actual primary completion date
2025-31-12
Actual study completion date
2025-31-12
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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