Last updated: 04/06/2021 09:00:06
A retrospective study to compare umeclidinium/vilanterol with tiotropium in an initial maintenance therapy population
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 for Time-to-First Inpatient Admission and Readmission in an Initial Maintenance Therapy Population
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, subjects often experience significant reductions in their health-related quality of life that correlate with disease severity. Tiotropium (TIO) is a long-acting muscarinic antagonists (LAMA), used commonly in the management of COPD. Further, those with severe breathlessness are recommended by Global Initiative for Chronic Obstructive Lung Disease (GOLD) to initiate therapy on a dual bronchodilator (i.e., LAMA + long-acting beta2 agonists [LABA]). Umeclidinium/vilanterol (UMEC/VI) is a once-daily single dose LAMA/LABA combination inhaler. Studies have shown that UMEC/VI was associated with lower lifetime medical costs and better cost-effectiveness than TIO. While UMEC/VI has demonstrated ability to reduce airway obstruction, its effect on COPD-related healthcare resource utilization (HRU) is sparse in the literature. The objective of this study will be to evaluate the time-to-first on-treatment, rate of on-treatment COPD-related inpatient admission and all-cause and COPD-related 30-day and 90-day readmission among subjects with COPD initiating treatment with UMEC/VI compared to TIO. A retrospective matched cohort design will be utilized with medical and pharmacy claims data including enrollment information from the Optum Clinformatics™ Data Mart Database for admission analysis during the identification period (01-Jan-2014 to 31-Dec-2018). Inpatient readmissions will be described among the subset of subjects who experience at least 1 on-treatment COPD-related inpatient admission, are alive at discharge, and are continuously enrolled for 30 days (for the 30-day readmission analysis) or 90 days (for the 90-day readmission analysis) following the discharge date of their first inpatient admission.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with time-to-first on-treatment COPD-related inpatient admission
Timeframe: At 3, 6, 9 and 12 months
Secondary outcomes:
Rate of on-treatment COPD-related inpatient admission
Timeframe: Up to 12 months
Number of subjects who experienced >=1 readmission
Timeframe: Up to 90 days
Rate of readmissions
Timeframe: Up to 90 days
Number of subjects who remained on the medication after their index discharge date
Timeframe: Up to 90 days
Number of subjects who switched the medication after their index discharge date
Timeframe: Up to 90 days
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-05-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Slade D, Ray R, Moretz C, Germain G, Laliberté F, Shen Q, Duh MS, MacKnight S, Hahn B. Hospital admission and readmission among US patients receiving umeclidinium/vilanterol or tiotropium as initial maintenance therapy for chronic obstructive pulmonary disease. Pulm Ther. 2021;
DOI: 10.1007/s41030-021-00151-y
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
May 2019 to November 2019
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
40+ years
Accepts healthy volunteers
No
- >=1 pharmacy claim for fixed-dose UMEC/VI or TIO during the identification period (between January 01, 2014 and December 31, 2018 [or September 30, 2018; depending on the most recent data available]). The date of the first prescription filled will be termed as the index date.
- >=1 medical claim with an international classification of diseases (ICD) diagnosis code for COPD in any position (primary or secondary) during the pre-index period or on the index date.
- >=1 pharmacy claim for inhaled corticosteroid (ICS-), LABA-, LAMA- containing controller during the pre-index period, excluding the index date.
- Pharmacy claims for non-index controller medications on the index date.
Inclusion and exclusion criteria
Inclusion criteria:
- >=1 pharmacy claim for fixed-dose UMEC/VI or TIO during the identification period (between January 01, 2014 and December 31, 2018 [or September 30, 2018; depending on the most recent data available]). The date of the first prescription filled will be termed as the index date.
- >=1 medical claim with an international classification of diseases (ICD) diagnosis code for COPD 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.
- (Readmission analyses only) >=1 on-treatment inpatient admission (i.e., hospitalization) in the post-index period and alive at discharge.
- (Readmission analyses only) Continuous enrollment with medical and pharmacy coverage of >=30 days after the index discharge date for the analysis of 30 Day readmissions, or >=90 days after the index discharge date for the analysis of 90 Day readmissions.
Exclusion criteria:
- >=1 pharmacy claim for inhaled corticosteroid (ICS-), LABA-, LAMA- containing controller during the pre-index period, excluding the index date.
- Pharmacy claims for non-index controller medications on the index date.
- Pharmacy claims for both UMEC/VI and TIO on the index date.
- Pharmacy claims for multiple inhaler triple therapy (MITT) on the index date.
- >=1 medical claim with a diagnosis for asthma 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
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
2019-05-11
Actual study completion date
2019-05-11
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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