Last updated: 03/07/2024 05:50:36

Comparison of Trelegy versus Multiple inhaler triple therapy (MITT) with Medicare insurance

GSK study ID
214316
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: Outcomes Following Initiation of Triple Therapy with Trelegy versus MITT Among Medicare Advantage with Part D Beneficiaries
Trial description: The purpose of this study is to provide real-world evidence on outcomes among Medicare Advantage with Part D (MAPD) beneficiaries diagnosed with Chronic obstructive pulmonary disease (COPD) who initiated Triple therapy (TT) with multiple inhalers versus a single inhaler with Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI).
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COPD exacerbation rate (any, severe, moderate) in participants who initiated TT with FF/UMEC/VI versus multiple inhalers

Timeframe: Up to 12 months before and after index date

Secondary outcomes:

Percentage of days covered as a measure of adherence with index therapy in COPD participants who initiated TT with FF/UMEC/VI versus multiple inhalers

Timeframe: Up to 12 months before and after index date

Number of participants with all-cause healthcare resource utilization who initiated TT with FF/UMEC/VI versus multiple inhalers

Timeframe: Up to 12 months before and after index date

Number of participants with COPD-related healthcare resource utilization who initiated TT with FF/UMEC/VI versus multiple inhalers

Timeframe: Up to 12 months before and after index date

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-22-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Bengtson L, Bogart M, Bunner S, DiRocco K, Gronroos N, Johnson M, et al. . Outcomes following initiation of triple therapy with fluticasone furoate/umeclidinium/vilanterol versus multiple-inhaler triple therapy among Medicare Advantage with Part D beneficiaries and those commercially enrolled for health care insurance in the United States. Int J Chron Obstruct Pulmon Dis. DOI: 10.2147/COPD.S424497 PMID: 38226396
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2021 to November 2021
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Inclusion criteria:
  • Greater than or equal to (>=)1 pharmacy claim for TT during the participant identification period of 01-Sep-2017 through 31-Mar-2019. TT will be defined as a pharmacy claim for FF/UMEC/VI or MITT for >=30 consecutive days of overlap in the days’ supply of Inhaled corticosteroids (ICS), Long-acting beta-2 agonist (LABA), and Long-acting muscarinic antagonist (LAMA). The index date will be the first date with TT during the participant identification period. For the MITT cohort the index date will be assigned as the first day with all three triple therapy components on hand.
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion criteria:
  • Greater than or equal to (>=)1 pharmacy claim for TT during the participant identification period of 01-Sep-2017 through 31-Mar-2019. TT will be defined as a pharmacy claim for FF/UMEC/VI or MITT for >=30 consecutive days of overlap in the days’ supply of Inhaled corticosteroids (ICS), Long-acting beta-2 agonist (LABA), and Long-acting muscarinic antagonist (LAMA). The index date will be the first date with TT during the participant identification period. For the MITT cohort the index date will be assigned as the first day with all three triple therapy components on hand.
  • >=2 medical claims with a diagnosis code for COPD in any position on separate dates of service during the study period.
  • Participants with >=40 years of age as of the year of the index date.
  • Continuous enrollment with Medicare Advantage with Part D medical and pharmacy coverage for 12 months prior to the index date (Baseline period).
  • Continuous enrollment with Medicare Advantage with Part D medical and pharmacy coverage for 12 months following the index date (follow-up period). Exclusion criteria:
  • >=1 day of overlapping days’ supply with an ICS, LABA, and LAMA during the Baseline period, excluding the index date.
  • >=1 medical claim with a diagnosis code for cystic fibrosis, lung cancer, or alpha-1 antitrypsin deficiency during the study period.
  • Pharmacy claims for both MITT and FF/UMEC/VI on the index date.
  • 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
2021-22-11
Actual study completion date
2021-22-11

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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