Last updated: 02/06/2024 05:09:25

Umeclidinium/vilanterol (UMEC/VI) versus Budesonide/formoterol (BUD/FM) as Initial Maintenance Therapy (IMT) in Chronic Obstructive Pulmonary Disease (COPD) subjects

GSK study ID
212922
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 BUD/FM for Medication Adherence and Rescue Medication Use in an Initial Maintenance Therapy COPD population
Trial description: This is a retrospective cohort study, which will include commercial and Medicare Advantage with Part D enrollees included in the Optum Research Database initiating treatment with UMEC/VI or BUD/FM between 01 January 2014 and 31 December 2017. The aim of this study is to compare adherence and rescue medication use between non-exacerbating COPD subjects who receive IMT with UMEC/VI versus BUD/FM. The purpose of this study is to compare the proportion of subjects adherent to treatment (proportion of days covered greater than equal to 80 percent [%]) between those initiating treatment with UMEC/VI compared to BUD/FM between 2014 and 2018. The study will use medical data from inpatient and outpatient, outpatient pharmacy, and enrollment data for commercially-insured and Medicare Advantage enrollees.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of subjects who are adherent to either UMEC/VI or BUD/FM medications

Timeframe: Up to 12 months (post-index period)

Secondary outcomes:

Rescue medication use in subjects treated with UMEC/VI or BUD/FM

Timeframe: Up to 12 months (post-index period)

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-26-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Moretz C, Cole AL, Mu G, Wu B, Guisinger A, Liu Y, Hahn B, Baylis L. Evaluation of medication adherence and rescue medication use in non-exacerbating patients with COPD receiving umeclidinium/vilanterol or budesonide/formoterol as initial maintenance therapy. Int J Chron Obstruct Pulmon Dis. 2020;15:2207-2215 DOI: 10.2147/COPD.S259850
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
August 2019 to August 2019
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Inclusion Criteria
  • Greater than equal to 1 outpatient pharmacy claim with a National Drug Code for fixed-dose UMEC/VI or BUD/FM during the identification period. The index date will be defined as the date of the earliest pharmacy claim for fixed-dose UMEC/VI or BUD/FM observed during the identification period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria
  • Greater than equal to 1 outpatient pharmacy claim with a National Drug Code for fixed-dose UMEC/VI or BUD/FM during the identification period. The index date will be defined as the date of the earliest pharmacy claim for fixed-dose UMEC/VI or BUD/FM observed during the identification period.
  • Greater than equal to inpatient or outpatient medical claim with an International Classification of Diseases, Ninth Revision (ICD-9) (prior to 01-October-2015) or International Classification of Diseases, Tenth Revision (ICD-10) (beginning 01-October-2015) diagnosis code for COPD in any position during the 1-year prior to (and inclusive of) the index date.
  • Age greater than equal to 40 years as of the index date.
  • Continuous enrollment with medical and pharmacy coverage for at least 1 year prior to and 1 year following the index date. Exclusion Criteria
  • Any outpatient pharmacy claim for Inhaled corticosteroid, long-acting beta agonist, or long-acting muscarinic antagonist containing controllers during the pre-index period.
  • Outpatient pharmacy claims for a non-index controller on the index date (including patients with claims for both UMEV/VI and BUD/FM on the index date).
  • Any moderate or severe COPD exacerbation in the 1 year prior to (and inclusive of) the index date.
  • Inpatient or outpatient medical claims with an ICD-9 or ICD-10 diagnosis code for asthma in any position in the year prior to (and inclusive of) the index date.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
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
2019-26-08
Actual study completion date
2019-26-08

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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