Last updated: 01/15/2024 10:00:27
Characteristics of new users of single and multiple-inhaler triple therapy for chronic obstructive pulmonary disease (COPD) in Japan
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Characteristics of patients with COPD newly treated with fluticasone/umeclidinium/vilanterol, budesonide/glycopyrronium/formoterol, or multiple inhaler triple therapy in the Medical Data Vision, Inc. clinical database
Trial description: The cross-sectional observational study will assess the Baseline participant level characteristics in terms of comorbidities, COPD burden, clinical characteristics, and prior medication use in COPD participants who are incident users of fluticasone/umeclidinium/vilanterol (TRELEGY 100®), budesonide/glycopyrronium/formoterol (Breztri Aerosphere), or multiple inhaled triple therapy (MITT), and initiated triple therapy on or after 01-Sep-2019, when TRELEGY 100 and Breztri Aerosphere were both available in Japan. TRELEGY 100 is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants treated with TRELEGY 100 regardless of prior triple therapy use
Timeframe: Up to 12 months prior index date
Number of participants treated with TRELEGY 100, Breztri Aerosphere, or MITT with no history of TRELEGY 100, Breztri Aerosphere, or MITT
Timeframe: Up to 12 months prior index date
Secondary outcomes:
Number of participants treated with TRELEGY 100, Breztri Aerosphere, or MITT as initial maintenance therapy with no history of Inhaled corticosteroid (ICS), Long-acting beta 2-agonist (LABA), or Long-acting muscarinic antagonist (LAMA)
Timeframe: Up to 12 months prior index date
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-03-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
NA
Study date(s)
July 2021 to January 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Participants with at least one pharmacy prescription claim(s) for TRELEGY 100, Breztri Aerosphere, or a MITT between 01-Sep-2019 and most recent data available at the time of the study. The index date will be earliest initiation of treatment. Specifically:
- a. Date of first prescription for TRELEGY 100
- Participants will be excluded if they used inhaled triple therapy (TRELEGY 100, Breztri Aerosphere, or open inhaled triple treatment) in the 12-month lookback period
- Participants will be excluded if they used any maintenance therapy (ICS, LABA, or LAMA containing medications) in the 12-month lookback period.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with at least one pharmacy prescription claim(s) for TRELEGY 100, Breztri Aerosphere, or a MITT between 01-Sep-2019 and most recent data available at the time of the study. The index date will be earliest initiation of treatment. Specifically:
- a. Date of first prescription for TRELEGY 100
- b. Date of first prescription for Breztri Aerosphere.
- c. Any of the following scenarios for MITT, occurring no earlier than the start of the study period:
- i. Prescription date of the last monotherapy component (ICS, LAMA, or LABA) overlapping with both of two preceding monotherapies (ICS, LAMA, or LABA).
- ii. Prescription date of last monotherapy component (LAMA or ICS) overlapping with preceding dual therapy (ICS/LABA or LAMA/LABA, respectively).
- iii. Prescription date of the last dual therapy component (ICS/LABA or LAMA/LABA) added to preceding monotherapy (LAMA or ICS, respectively).
- Participants with age greater than or equal to (>=) 40 at index date.
- Participants with >=2 outpatient or >=1 hospitalization record with an International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for COPD (J42, J43 or J44) in the 12 calendar months prior and including the index calendar month.
- Participants with >=1 outpatient or hospitalization record with any ICD-10 diagnosis code in the 6-month period prior to the 12-month lookback period.
- New users as of the index date. Defined as follows (not mutually exclusive):
- a: No record of TRELEGY 100 in the 12-month lookback period.
- b: No record of triple therapy (TRELEGY 100, Breztri Aerosphere, or MITT) in the 12-month lookback period.
- c: No record of any maintenance therapy (ICS, LABA, or LAMA-containing therapies) in the 12-month lookback period.
- Participants will be assigned to their respective study cohorts based on whether the index prescription record was for TRELEGY 100, Breztri Aerosphere, or MITT.
Exclusion criteria:
- Participants will be excluded if they used inhaled triple therapy (TRELEGY 100, Breztri Aerosphere, or open inhaled triple treatment) in the 12-month lookback period
- Participants will be excluded if they used any maintenance therapy (ICS, LABA, or LAMA containing medications) in the 12-month lookback period.
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
2022-03-01
Actual study completion date
2022-03-01
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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