Last updated: 02/01/2024 14:50:29

Impact of FF/UMEC/VI on COPD Exacerbations

GSK study ID
213946
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: COPD Exacerbations Before and After Initiation of FF/UMEC/VI
Trial description: The purpose of this study is to examine the impact of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) initiation on Chronic Obstructive Pulmonary Disease (COPD) exacerbations, COPD exacerbation-related costs, and all-cause and COPD-related healthcare resource utilization and costs experienced by COPD participants in the real world. This will be a retrospective study of commercial and Medicare Advantage with Part D (MAPD) enrollees, using administrative claims data for the period of 1-Sep-2016 through 31-Dec-2019.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with COPD exacerbations (any, severe) within 12 months prior to index date

Timeframe: Within 12 months prior to index date

Number of participants with COPD exacerbations (any, severe) up to 12 months after index date

Timeframe: Up to 12 months after index date

COPD exacerbation rate (any, severe) within 12 months prior to index date

Timeframe: Within 12 months prior to index date

COPD exacerbation rate (any, severe) up to 12 months after index date

Timeframe: Up to 12 months after index date

Number of participants with COPD exacerbation-related cost within 12 months prior to index date

Timeframe: Within 12 months prior to index date

Number of participants with COPD exacerbation-related cost up to 12 months after index date

Timeframe: Up to 12 months after index date

Secondary outcomes:

Number of participants with all-cause healthcare resource utilization before and after index date

Timeframe: Up to 12 months before and after index date

Number of participants with COPD-related healthcare resource utilization before and after index date

Timeframe: Up to 12 months before and after index date

Number of participants with all-cause costs of care before and after index date

Timeframe: Up to 12 months before and after index date

Number of participants with COPD-related costs of care before and after index date

Timeframe: Up to 12 months before and after index date

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-18-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Bengtson L, Bogart M, Bunner S, Hanania N, Ismaila A. COPD exacerbations, costs, and health care resource utilization before and after initiation of fluticasone furoate/umeclidinium/vilanterol in routine care in the USA. Int J Chron Obstruct Pulmon Dis. 2023-03-24;18: 407-418. DOI:10.2147/COPD.S378867 PMID: 36998390
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
August 2020 to December 2020
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Greater than or equal to (>=)1 pharmacy claim for FF/UMEC/VI during the participant identification period of 1-Sep-2017 and 31-Dec-2018. The index date will be the date of the first pharmacy claim for FF/UMEC/VI.
  • >=2 medical claims with a diagnosis code for COPD in any position on separate dates of service during the study period (Baseline or follow-up diagnosis).
  • >=1 medical claim with a diagnosis code for asthma, cystic fibrosis, or lung cancer during the study period.
  • >=1 pharmacy claim for FF/UMEC/VI during the Baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Greater than or equal to (>=)1 pharmacy claim for FF/UMEC/VI during the participant identification period of 1-Sep-2017 and 31-Dec-2018. The index date will be the date of the first pharmacy claim for FF/UMEC/VI.
  • >=2 medical claims with a diagnosis code for COPD in any position on separate dates of service during the study period (Baseline or follow-up diagnosis).
  • >=30 consecutive days of overlap in the days’ supply of all three triple therapy components (Inhaled Corticosteroid [ICS], Long-acting Beta-agonist [LABA], and Long-acting Muscarinic Antagonist [LAMA]) during the 12 months prior to the index date (i.e., multiple inhaler triple therapy [MITT]).
  • >=40 years of age as of the year of the index date.
  • Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (Baseline period).
  • Continuous enrollment with medical and pharmacy coverage for 12 months following the index date (follow-up period).
Exclusion criteria:
  • >=1 medical claim with a diagnosis code for asthma, cystic fibrosis, or lung cancer during the study period.
  • >=1 pharmacy claim for FF/UMEC/VI during the Baseline period.
  • Unknown age, gender, geographic region, or business line.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
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
2020-18-12
Actual study completion date
2020-18-12

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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