Last updated: 03/25/2024 10:50:28

Efficacy of Triple-therapy (fluticasone furoate/vilanterol/umeclidinium) in participants with comorbid asthma and chronic obstructive pulmonary disease (COPD)

GSK study ID
214321
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: Real-world Study Assessing Exacerbation and Healthcare Burden Among COPD Patients with Comorbid Asthma Triple-therapy (fluticasone furoate/vilanterol/umeclidinium)
Trial description: The purpose of this study is to understand the exacerbation reduction potential of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in COPD participants in relation to healthcare resources utilization (HCRU) and related costs among participants with comorbid asthma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Rate of COPD exacerbations (any, severe, moderate)

Timeframe: Up to 12 months pre-index and 12 months post-index date

Secondary outcomes:

Number of participants with all cause and COPD-related HCRU

Timeframe: Up to 12 months pre-index and 12 months post-index date

Total costs associated with all cause and COPD related HCRU

Timeframe: Up to 12 months pre-index and 12 months post-index date

Rate of asthma exacerbations (any, severe, moderate)

Timeframe: Up to 12 months pre-index and 12 months post-index date

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-03-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Emmeline Igboekwe, Sumit Verma, Rosirene Paczkowski. Real-world disease burden and healthcare resource utilization among patients with COPD and asthma using triple therapy (FF/UMEC/VI) in the United States. Int J Chron Obstruct Pulmon Dis. DOI: 10.2147/COPD.S423993 PMID: 38292138
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate/vilanterol/umeclidinium bromide
Collaborators
NA
Study date(s)
August 2021 to December 2021
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Participants with greater than or equal to (>=)2 pharmacy or administration claim for FF/UMEC/VI between 01-Oct-2017 and 31-Mar- 2019. Drugs will be identified in the data using both National Drug Code (NDC) and Healthcare Common Procedure Coding System (HCPCS) codes (if available) based on the generic name; The date of the first medication claim for FF/UMEC/VI will be designated as the index date.
  • Participants with >=2 diagnosis claims for COPD on any position during the study period 01-Oct-2016 and 31-Mar-2020 on different dates.
  • Participants with >=1 diagnosis claim for cystic fibrosis or lung cancer during the 12-month Baseline period; or
  • Participants with >=1 prescription claim for any triple-therapy, including FF/UMEC/VI or multiple concurrent inhaler therapy, prior to index prescription.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with greater than or equal to (>=)2 pharmacy or administration claim for FF/UMEC/VI between 01-Oct-2017 and 31-Mar- 2019. Drugs will be identified in the data using both National Drug Code (NDC) and Healthcare Common Procedure Coding System (HCPCS) codes (if available) based on the generic name; The date of the first medication claim for FF/UMEC/VI will be designated as the index date.
  • Participants with >=2 diagnosis claims for COPD on any position during the study period 01-Oct-2016 and 31-Mar-2020 on different dates.
  • Participants with age >=40 years as of the index date.
  • Participants with continuous health plan enrollment with medical and pharmacy benefits for >=12 months pre-treatment date.
  • Participants with continuous health plan enrollment with medical and pharmacy benefits for >=12 months follow-up post-treatment initiation period; and the follow-up period will consist of the 12 month-period starting the day after the index date.
  • Participants with >=2 diagnosis claim for asthma anytime during the study period 01-Oct-2016 and 31-Mar-2020 on different dates.
Exclusion criteria:
  • Participants with >=1 diagnosis claim for cystic fibrosis or lung cancer during the 12-month Baseline period; or
  • Participants with >=1 prescription claim for any triple-therapy, including FF/UMEC/VI or multiple concurrent inhaler therapy, prior to index prescription.

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
2021-03-12
Actual study completion date
2021-03-12

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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