Last updated: 02/19/2024 10:20:13
A study to compare umeclidinium/vilanterol with tiotropium for Time-to-First Moderate or Severe COPD Exacerbation
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 Moderate or Severe COPD Exacerbation in 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. The objectives of this study are to evaluate and compare COPD exacerbations, medical costs (i.e., COPD-related), and medication adherence between COPD subjects who initiate maintenance therapy with UMEC/VI or 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 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:
Time-to-first on-treatment COPD-related moderate or severe exacerbation
Timeframe: Up to 12 months
Secondary outcomes:
Frequency of COPD-related moderate or severe exacerbations
Timeframe: Up to 12 months
COPD-related medical costs over the on-treatment period
Timeframe: Up to 12 months
Proportion of days covered (PDC)
Timeframe: Up to 12 months
Proportion of days covered (PDC >=0.8)
Timeframe: Up to 12 months
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, Mahendran M, Hahn B. Time-to-first exacerbation, adherence, and medical costs among US patients receiving umeclidinium/vilanterol or tiotropium as initial maintenance therapy for chronic obstructive pulmonary disease: a retrospective cohort study. BMC Pulm Med. 2021;21:253
DOI: 10.1186/s12890-021-01612-5
PMID: 34332555
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Analysis Group
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 01-Jan-2014 and 31-Dec-2017 [or 30-Sep-2017; 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
Inclusion and exclusion criteria
Inclusion criteria:
- >=1 pharmacy claim for fixed-dose UMEC/VI or TIO during the identification period (between 01-Jan-2014 and 31-Dec-2017 [or 30-Sep-2017; 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 and after 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 Exclusion Criteria
- >=1 pharmacy or medical claim for inhaled corticosteroid (ICS-), LABA or LAMA containing controller during the pre-index period excluding index date.
- Pharmacy or medical claims for non-index controller medications on the index date.
- Pharmacy or medical claims for both UMEC/VI and TIO on the index date.
- Pharmacy or medical claims for multiple inhaler triple therapy (MITT) (i.e., ICS + LAMA + LABA) on the index date
- >=1 medical claim with a diagnosis for asthma in the pre-index period.
- 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 subject attrition. Moreover, if the proportion of subjects excluded is large, a sensitivity analysis could be conducted with and without excluding these subjects.
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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