Last updated: 11/04/2025 06:10:49

Comparative outcome of single-inhaler triple therapies (SITT) in participants with chronic obstructive pulmonary disease (COPD)

GSK study ID
300180
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
0
Primary completion date:
2026-30-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma, Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Analysis Group
Study date(s)
March 2025 to January 2026
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 (>=) 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.
Exclusion criteria:

    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.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website