Last updated: 06/11/2025 14:10:27

Retrospective study of participants on dual therapy prior to Trelegy Step-up

GSK study ID
217417
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: Characteristics and outcomes of patients on dual therapy ICS-LABA prior to Trelegy Step-up
Trial description: This study will help understand the characteristics of participants who stepped up to a Single Inhaler Triple Therapy (SITT) that is Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) from Inhaled Corticosteroids/ Long-acting beta2-agonist (ICS/LABA).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Summary of socio-demographic characteristics in overall and participants exposed to ICS/LABA

Timeframe: Baseline (Up to 12 months)

Summary of clinical characteristics in overall and participants exposed to ICS/LABA

Timeframe: Baseline (Up to 12 months)

Secondary outcomes:

Asthma-related clinical characteristics in overall and participants exposed to ICS/LABA

Timeframe: 12 months prior to Index Date

Rate of asthma exacerbations in overall and participants exposed to ICS/LABA

Timeframe: 12 months prior to Index Date

Time-to-triple therapy following exacerbations in overall and participants exposed ICS/LABA

Timeframe: 12 months prior to Index Date

All-cause and asthma-related healthcare resource utilization (HCRU) in overall and participants exposed to ICS/LABA

Timeframe: 12 months prior to Index Date

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-23-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone furoate/vilanterol/umeclidinium bromide
Collaborators
Not applicable
Study date(s)
January 2023 to February 2023
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • At least 1 pharmacy claim for FF/UMEC/VI-100 or FF/UMEC/VI-200 during the participant identification period of 01 September 2017 through 31 March 2021. The index date will be the date of the first pharmacy claim for either FF/UMEC/VI-100 or FF/UMEC/VI-200
  • At least 18 years of age as of the first day of the index year.
  • A person meeting any of the following criteria will be excluded from the study population:
  • Triple therapy during Baseline (excluding index date), defined as >= 30 consecutive days of overlap in the day’s supply of ICS, LABA, and Long-acting Muscarinic Antagonist (LAMA).
Inclusion and exclusion criteria
Inclusion criteria:
  • At least 1 pharmacy claim for FF/UMEC/VI-100 or FF/UMEC/VI-200 during the participant identification period of 01 September 2017 through 31 March 2021. The index date will be the date of the first pharmacy claim for either FF/UMEC/VI-100 or FF/UMEC/VI-200
  • At least 18 years of age as of the first day of the index year.
  • Continuous enrollment with medical and pharmacy coverage for twelve months prior to the index date (Baseline period).
  • Continuous enrollment with medical and pharmacy coverage for twelve months following the index date (follow-up period).
  • Must have greater than or equal to (>=) 30 consecutive day’s supply of ICS-LABA during the twelve months prior to the index date (Baseline period).
  • At least 2 medical claims with a diagnosis code for asthma in any position on separate dates of service during the study period (Baseline or follow-up diagnoses).
Exclusion criteria:
  • A person meeting any of the following criteria will be excluded from the study population:
  • Triple therapy during Baseline (excluding index date), defined as >= 30 consecutive days of overlap in the day’s supply of ICS, LABA, and Long-acting Muscarinic Antagonist (LAMA).
  • Unknown age, sex, geographic region, or business line, as internal data review has suggested participants missing these key elements have unreliable data overall.
  • At least 1 medical claim with a diagnosis code for cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin during the study period.
  • At least 2 medical claims with a diagnosis code for Chronic Obstructive Pulmonary Disease (COPD) in any position on separate dates of service during the study period.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
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
2023-23-02
Actual study completion date
2023-23-02

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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