Last updated: 07/31/2020 02:10:06

Comparative Effectiveness of Umeclidinium/Vilanterol versus Tiotropium Bromide/Olodaterol

GSK study ID
207968
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: Comparative Effectiveness of Umeclidinium/Vilanterol versus Tiotropium Bromide/Olodaterol
Trial description: This study will include data of subjects with chronic obstructive pulmonary disease (COPD). This study is a retrospective database analysis to assess non-inferiority and potentially superiority of Umeclidinium/Vilanterol (UMEC/VI) versus Tiotropium Bromide/Olodaterol (TIO/OLO) among subjects initiating these rescue medications use (inhaled or nebulized short-acting beta-agonist [SABA] or short acting muscarinic antagonist [SAMA] medication). This study will also examine medication adherence among the subjects. This study will include subjects from commercial, Medicare Advantage with Part D (MAPD), and Part D only (PDP) subjects treated with UMEC/VI or TIO/OLO between 01 June 2015 and 30 June 2016 that is the identification (ID) period. The database for the study will be collected from medical data, pharmacy data, and enrollment information in Optum Research Database (ORD). All subjects will be enrolled in continuous health plan for 24 months where 12 months in the pre-index period and 12 months in post-index period. The index date for each subject will be date of the first pharmacy claim for UMEC/VI or TIO/OLO observed during ID period of 01 June 2015 to 30 June 2016.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Rate of rescue medication

Timeframe: 12 Months post-index period

Number of rescue medication units

Timeframe: 12 Months post-index period

Number of units nebulized of rescue medications

Timeframe: 12 Months post-index period

Number of units inhaled of rescue medications

Timeframe: 12 Months post-index period

Secondary outcomes:

Number of subjects with post-index adherence

Timeframe: 12 Months post-index period

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2018-17-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Moretz C, Bengtson L, Sharpsten L, Koep E, Le L, Tong J, Stanford R, Hahn B, Ray R.Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol.Int J Chron Obstruct Pulmon Dis.2019;14:2047—2060 DOI: 10.2147/COPD.S213520
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
olodaterol, olodaterol/tiotropium bromide, tiotropium bromide, umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Optum
Study date(s)
February 2018 to July 2018
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Not applicable
  • Greater than or equal to 1 pharmacy claim for UMEC/VI or TIO/OLO during the ID period; both UMEC/VI and TIO/OLO are indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in subjects with COPD and are not indicated for relief of acute bronchospasm or for the treatment of asthma. Index date is the first claim for UMEC/VI or TIO/OLO observed during the ID period.
  • Age >=40 years as of the year of the index date.
  • A pharmacy claim for an Inhaled corticosteroid (ICS), LABA, or LAMA during the pre-index period.
  • Pharmacy fills for both UMEC/VI and TIO/OLO on the index date
Inclusion and exclusion criteria
Inclusion criteria:
  • Greater than or equal to 1 pharmacy claim for UMEC/VI or TIO/OLO during the ID period; both UMEC/VI and TIO/OLO are indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in subjects with COPD and are not indicated for relief of acute bronchospasm or for the treatment of asthma. Index date is the first claim for UMEC/VI or TIO/OLO observed during the ID period.
  • Age >=40 years as of the year of the index date.
  • Continuous enrollment with medical and pharmacy coverage of 12 months in the pre-index period and of 12 months in the post-index period for commercial and MAPD subjects; continuous enrollment with pharmacy coverage of 12 months in the pre-index period and of 12 months in the post-index period for PDP subjects.
Exclusion criteria:
  • A pharmacy claim for an Inhaled corticosteroid (ICS), LABA, or LAMA during the pre-index period.
  • Pharmacy fills for both UMEC/VI and TIO/OLO on the index date
  • Pharmacy fills for open triple therapy (that is, ICS, LABA, and LAMA) on the index date.
  • COPD exacerbation on the index date
  • Missing demographic information

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
2018-17-07
Actual study completion date
2018-17-07

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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