Last updated: 07/31/2020 02:00:14

Comparative Effectiveness of Umeclidinium/Vilanterol versus ICS/LABA Therapy

GSK study ID
207969
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 ICS/LABA Therapy
Trial description: Umeclidinium/vilanterol (UMEC/VI) is a once-daily single inhaler combination with a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) approved for treatment of chronic obstructive pulmonary disease (COPD). Efficacy results from clinical trials have shown that UMEC/VI improves lung function compared to fluticasone propionate/salmeterol (FSC). However, there are limited effectiveness results on outcomes for subjects initiating UMEC/VI therapy compared to subjects initiating FSC. The purpose of this study is to examine medication adherence, incidence of first COPD exacerbation and incidence of open triple therapy (inhaled corticosteroid [ICS]+LABA+LAMA), among subjects initiating treatment with UMEC/VI or FSC. This is a retrospective cohort study, which will include commercial and Medicare Advantage with Part D (MAPD) enrollees initiating treatment with UMEC/VI or FSC between 01 April 2014 and 31 August 2016 (the identification period). The study will use medical data, pharmacy data, and enrollment information in the Optum Research Database (ORD). The maximum observation period for each subject is 24 months, which includes 12 months in the pre-index period and 12 months in the post-index period.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with medication adherence

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

Secondary outcomes:

Incidence of first COPD exacerbation

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

Incidence rate of open triple therapy

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

Number of subjects with COPD-related medical costs

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

Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2018-05-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Moretz C, Sharpsten L, Bengtson L, Koep E, Le L, Tong J, Stanford R, Hahn B, Ray R. Real-world effectiveness of umeclidinium/vilanterol versus fluticasone propionate/salmeterol as initial maintenance therapy for chronic obstructive pulmonary disease (COPD): a retrospective cohort study. Int J Chron Obstruct Pulmon Dis. 2019;14:1721-1737 DOI: 10.2147/COPD.S204649
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Optum
Study date(s)
February 2018 to June 2018
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Not applicable
  • More than or equal to one pharmacy claim for UMEC/VI or FSC during the identification period. Index date is the date of first claim for UMEC/VI or FSC observed during the identification period.
  • More than or equal to one inpatient hospitalization or >=2 outpatient (i.e., office or other outpatient) and/or emergency department visits within one year with a diagnosis code for COPD in any position during the pre‐index through the identification period. COPD diagnosis must occur before or on the date of the index fill.
  • A pharmacy claim for an ICS‐, LABA‐, or LAMA‐containing controller during the pre‐index period.
  • Pharmacy fills for both UMEC/VI and FSC on the index date.
Inclusion and exclusion criteria
Inclusion criteria:
  • More than or equal to one pharmacy claim for UMEC/VI or FSC during the identification period. Index date is the date of first claim for UMEC/VI or FSC observed during the identification period.
  • More than or equal to one inpatient hospitalization or >=2 outpatient (i.e., office or other outpatient) and/or emergency department visits within one year with a diagnosis code for COPD in any position during the pre‐index through the identification period. COPD diagnosis must occur before or on the date of the index fill.
  • International Classification of Diseases, Tenth Revision, (ICD‐10) diagnosis codes will be used during the portion of the identification period starting 01 October 2015, prior to which International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes will be used. ICD‐10 codes J44.0, J44.1, and J44.9 include chronic obstructive asthma, therefore, ICD‐9 codes for chronic obstructive asthma (493.2x) also will be included in order to provide coding consistency across the ICD‐9 / ICD‐10 transition.
  • Variables will be created to identify subjects with a diagnosis at any time during the pre-index period for inclusion in the inverse probability of treatment weighting model (IPTW) model.
  • 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.
Exclusion criteria:
  • A pharmacy claim for an ICS‐, LABA‐, or LAMA‐containing controller during the pre‐index period.
  • Pharmacy fills for both UMEC/VI and FSC on the index date.
  • Pharmacy fills for open triple therapy (i.e., ICS, LABA, and LAMA) on the index date.
  • COPD exacerbation on index date.
  • Missing demographic information.
  • Asthma diagnosis in the pre-index period.

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
2018-05-06
Actual study completion date
2018-05-06

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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