Last updated: 02/06/2024 06:03:06

Umeclidinium/Vilanterol (UMEC/VI) versus Tiotropium (TIO) hospitalization among Medicare Beneficiaries

GSK study ID
214310
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: UMEC/VI compared to TIO for Time-to-First Inpatient Admission and Readmission in an Initial Maintenance Therapy Population Among Medicare Beneficiaries
Trial description: This observational study aims to compare inpatient admissions rate and time to inpatient admissions among Medicare beneficiaries with Chronic Obstructive Pulmonary Disease (COPD) who initiate therapy with UMEC/VI versus TIO.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Time-to-first on-treatment COPD-related inpatient admission

Timeframe: 3, 6, 9 and 12 months post-index date

Secondary outcomes:

Rate of on-treatment COPD-related inpatient admissions

Timeframe: Up to 12 months post-index date

Percentage of participants experiencing all-cause or COPD-related readmission

Timeframe: Up to 30 days and 90 days post-discharge

Rate of all-cause or COPD-related readmissions

Timeframe: Up to 30 days and 90 days post-discharge

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-23-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide/vilanterol
Collaborators
Not applicable
Study date(s)
August 2021 to May 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
No
  • Inclusion criteria:
  • Participants with greater than or equal to (>=)1 pharmacy claim for fixed-dose UMEC/VI or TIO during the identification period between 01-Jan-2015 and 28-Feb-2020. The date of the first prescription filled will be termed as the index date.
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion criteria:
  • Participants with greater than or equal to (>=)1 pharmacy claim for fixed-dose UMEC/VI or TIO during the identification period between 01-Jan-2015 and 28-Feb-2020. The date of the first prescription filled will be termed as the index date.
  • >=1 medical claim with an International Classification of Diseases (ICD) diagnosis code for COPD in any position during the pre-index period (including index date).
  • 12 months continuous capture of participant’s health plan pre-index date (pre-index period).
  • Medicare insurance both at index and throughout pre- and post-index periods.
  • >=65 years of age at start of pre-index period.
  • Readmission analyses only: a) >=1 on-treatment inpatient admission (hospitalization) in the post-index period and alive at discharge. b) Continuous enrollment with medical and pharmacy coverage of >=30 days after the index discharge date for the analysis of 30-day readmissions, or >=90 days after the index discharge date for the analysis of 90-day readmissions. Exclusion criteria:
  • Participants with >=1 pharmacy claim for Inhaled Corticosteroid (ICS), Long-Acting Beta-2 Agonist (LABA), or Long-Acting Muscarinic Antagonist (LAMA) containing controller during the pre-index period, excluding the index date.
  • Pharmacy claims for non-index controller medications on the index date.
  • Pharmacy claims for both UMEC/VI and TIO on the index date.
  • Pharmacy claims for multiple inhaler triple therapy (MITT) for fixed dose triple therapy (ICS + LAMA + LABA) on the index date.
  • >=1 medical claim with a diagnosis for asthma in the pre-index period, including index date.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

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
2022-23-05
Actual study completion date
2022-23-05

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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