Last updated: 12/03/2023 09:10:45

Umeclidinium/Vilanterol (UMEC/VI) vs Fluticasone Propionate/Salmeterol (FP/SAL) cost and comorbidities

GSK study ID
209601
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 FP/SAL as Initial Maintenance Therapy in High-Cost and High-Comorbidity COPD Patients
Trial description: This study aims to evaluate and compare chronic obstructive pulmonary disease (COPD)-related medical costs and exacerbations among high-cost and high-comorbidity COPD participants who received UMEC/VI versus FP/SAL as their initial maintenance therapy. A retrospective matched cohort design will be utilized with medical and pharmacy claims data including enrollment information from the Optum Clinformatics™ Data Mart Database. COPD participants with first pharmacy claim of fixed-dose UMEC/VI or FP/SAL between January 1, 2014 and December 31, 2018 will be identified (date of the first prescription filled is considered index date). COPD-related and all-cause medical costs will be assessed during the on-treatment period following the index date. Optum Clinformatics is a trademark of Optum group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COPD related total medical costs

Timeframe: Up to 4 years

Secondary outcomes:

All-cause total medical costs

Timeframe: Up to 4 years

Time-to-first on-treatment COPD-related moderate or severe exacerbation

Timeframe: Up to 4 years

Rate of COPD-related moderate or severe exacerbations over the on-treatment period

Timeframe: Up to 4 years

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-14-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Analysis Group
Study date(s)
September 2019 to November 2019
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • >=1 pharmacy claim for fixed-dose UMEC/VI or FP/SAL during the identification period (between January 1, 2014 and December 31, 2018). The date of the first prescription filled will be termed as the index date.
  • >=1 medical claim with International Classification of Diseases (ICD) diagnosis code for COPD (ICD-9th Revision (9)- Clinical Modification (CM): 491.x, 492.x, 496.x; ICD-10th Revision (10)-CM: J41–J44) in any position (primary or secondary) during the pre-index period or on the index date.
  • >=1 medical claim with a diagnosis for asthma (ICD-9-CM: 493.xx; ICD-10-CM: J45.3, J45.4, J45.5, J45.9) in the pre-index or post-index period, including the index date.
  • >=1 pharmacy or medical claim for ICS-, LABA-, or LAMA-containing therapy during the pre-index period, excluding the index date.
Inclusion and exclusion criteria
Inclusion criteria:
  • >=1 pharmacy claim for fixed-dose UMEC/VI or FP/SAL during the identification period (between January 1, 2014 and December 31, 2018). The date of the first prescription filled will be termed as the index date.
  • >=1 medical claim with International Classification of Diseases (ICD) diagnosis code for COPD (ICD-9th Revision (9)- Clinical Modification (CM): 491.x, 492.x, 496.x; ICD-10th Revision (10)-CM: J41–J44) in any position (primary or secondary) during the pre-index period or on the index date.
  • Continuous enrollment with medical and pharmacy coverage of >=12 months prior to the index date. The 12 months prior to the index date (and including the index date) will be termed the pre-index period.
  • >=40 years of age in the year of the index date.
  • Defined as high-comorbidity. Participants with a Quan-Charlson Comorbidity Index (CCI) greater or equal to 3 during the 12-month pre-index period will be classified as high-comorbidity. A CCI greater or equal to 2 for identifying participants as high-comorbidity will also be evaluated in a sensitivity analysis.
  • Defined as high-cost. High-cost participants are defined as those whose costs are in the 80th or greater percentile of the cost distribution. Therefore, COPD participants will be classified as high-cost and selected into the study if their pre-index all-cause medical costs exceed the 80th percentile threshold cost identified in the overall initial maintenance therapy (IMT) COPD population. The overall IMT COPD population includes both the UMEC/VI and FP/SAL IMT COPD cohorts as well as participants initiated on other types of IMT with no inhaled corticosteroid (ICS)-, long-acting beta agonists (LABA)-, long-acting muscarinic-antagonists (LAMA)- controllers within 12 months prior to treatment initiation.
Exclusion criteria:
  • >=1 medical claim with a diagnosis for asthma (ICD-9-CM: 493.xx; ICD-10-CM: J45.3, J45.4, J45.5, J45.9) in the pre-index or post-index period, including the index date.
  • >=1 pharmacy or medical claim for ICS-, LABA-, or LAMA-containing therapy during the pre-index period, excluding the index date.
  • >=1 pharmacy or medical claim for non-index controller medication on the index date.
  • >=1 pharmacy or medical claim for both index medications (i.e., UMEC/VI and FP/SAL) on the index date.
  • >=1 pharmacy or medical claim for multiple inhaler triple therapy (MITT) (i.e., ICS + LAMA + LABA) on the index date.
  • Moderate or severe COPD exacerbation on the 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
2019-14-11
Actual study completion date
2019-14-11

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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