Last updated: 02/06/2024 04:51:08
UMEC/VI as initial maintenance therapy in high-cost and high-comorbidity COPD participants
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: UMEC/VI compared to B/F as Initial Maintenance Therapy in High-Cost and High-Comorbidity COPD Patients
Trial description: Chronic obstructive pulmonary disease (COPD) is a prevalent respiratory disease characterized by impaired airflow due to chronic inflammation of air passages in the lung. Due to the progressive nature of COPD-related symptoms, participants often experience significant reductions in their health-related quality of life that correlate with disease severity. Umeclidinium (UMEC/ Vilanterol [VI]) has shown improved lung function in comparison to Budesonide/Formoterol (B/F); however, interest in the potential cost-savings associated with this therapy require further investigations. Among COPD participants having multiple comorbidities and high pre-treatment healthcare costs, medical costs following treatment initiation with UMEC/VI as compared to B/F could provide insight into the additional economic benefits of UMEC/VI to this particular population. The objectives of this study are to evaluate and compare COPD-related medical costs and exacerbations among high-cost and high-comorbidity COPD participants who received UMEC/VI versus B/F as their initial maintenance therapy (IMT). A retrospective matched cohort design will be utilized with medical and pharmacy claims data including enrollment information from the Optum Clinformatics™ Data Mart Database during the identification period (01-Jan-2014 to 31-Dec-2018). Optum Clinformatics is a registered trademark of Optum.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with COPD related medical cost over on-treatment post-index period
Timeframe: Up to 5 years
Secondary outcomes:
Number of participants with all cause medical cost reported per participant per year
Timeframe: Up to 5 years
Time-to-first on-treatment COPD-related moderate or severe exacerbation
Timeframe: Up to 5 years
Rate of COPD-related moderate or severe exacerbations
Timeframe: Up to 5 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
Not applicable
Study date(s)
September 2019 to November 2019
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Participants with greater than or equal to 1 pharmacy claim for fixed-dose UMEC/VI or B/F 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.
- Participants with greater than or equal to 1 medical claim with ICD diagnosis code for COPD (ICD-9-CM: 491.x, 492.x, 496.x; ICD-10-CM: J41–J44) in any position (primary or secondary) during the pre-index period or on the index date.
- Participants with greater than or equal to 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.
- Participants with greater than or equal to 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:
- Participants with greater than or equal to 1 pharmacy claim for fixed-dose UMEC/VI or B/F 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.
- Participants with greater than or equal to 1 medical claim with ICD diagnosis code for COPD (ICD-9-CM: 491.x, 492.x, 496.x; ICD-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 greater than or equal to 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.
- Participants with greater than equal to 40 years of age in the year of the index date.
- Defined as high-comorbidity; Participants with a CCI greater or equal to 3 during the 12-month pre-index period will be classified as high-comorbidity, as suggested by previous literature. 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; based on recent literature, high-cost participants are often 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 IMT COPD population. We will also explore the 50th percentile threshold cost in a sensitivity analysis. The overall IMT COPD population includes both the UMEC/VI and B/F IMT COPD cohorts as well as patients initiated on other types of IMT with no IMT with no Inhaled Corticosteroid (ICS)-, Long-Acting Beta2 Agonist (LABA)-, Long-Acting Muscarinic Antagonist (LAMA)- controllers within 12 months prior to treatment initiation.
- The overall IMT COPD population includes both the UMEC/VI and B/F IMT COPD cohorts as well as patients initiated on other types of IMT with no ICS-, LABA-, LAMA- controllers within 12 months prior to treatment initiation.
Exclusion criteria:
- Participants with greater than or equal to 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.
- Participants with greater than or equal to 1 pharmacy or medical claim for ICS-, LABA-, or LAMA-containing therapy during the pre-index period, excluding the index date.
- Participants with greater than or equal to 1 pharmacy or medical claim for non-index controller medication on the index date.
- Participants with greater than or equal to 1 pharmacy or medical claim for both index medications (i.e., UMEC/VI and B/F) on the index date.
- Participants with greater than or equal to 1 pharmacy or medical claim for multiple inhaler triple therapy (MITT) (i.e., ICS + LAMA + LABA) on the index date.
- Participants with moderate or severe COPD exacerbation on the index date. A feasibility analysis will be conducted to assess the impact of this exclusion criterion on the participants attrition. Moreover, if the proportion of participants excluded is large, a sensitivity analysis could be conducted without excluding these participants.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
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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