Last updated: 02/19/2024 10:40:59
UMEC/VI as an 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 TIO 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 to be associated with improved lung function in comparison to Tiotropium (TIO); 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 TIO 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 TIO 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 TIO during the identification period (between 01 January 2014 and 31 December 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 (International Classification of Diseases, 9th Revision, Clinical Modification [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 TIO during the identification period (between 01 January 2014 and 31 December 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 (International Classification of Diseases, 9th Revision, Clinical Modification [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 or 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 Quan-Charlson Comorbidity Index (CCI) greater or equal to 2 for identifying patients 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 equal or 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 TIO IMT COPD cohorts as well as participants initiated on other types of IMT with no Inhaled Corticosteroid (ICS)-, Long-Acting Beta2 Agonist (LABA)-, Long-Acting Muscarinic Antagonist (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 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 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 participant's 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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website