Last updated: 08/01/2025 04:20:26
Study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among participants with chronic obstructive pulmonary disease
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Cohort study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among patients with chronic obstructive pulmonary disease using health insurance claims data provided by Medical Data Vision Co., Ltd. in Japan
Trial description: This is a retrospective cohort post-marketing surveillance study (PASS) to estimate incidence of community-acquired pneumonia (CAP) in users of Trelegy 100 or multiple inhaler triple therapy (MITT) among participants with chronic obstructive pulmonary disease (COPD) using health insurance claims (outpatient and inpatient) data provided by Medical Data Vision Company Limited (MDV) (Tokyo, Japan). Trelegy 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 hospitalized due to CAP
Timeframe: Up to 1440 days
Secondary outcomes:
Number of hospitalization per participant year
Timeframe: Up to 1440 days
Number of participants with COPD administered MITT and Trelegy
Timeframe: Up to 1440 days
Characteristics of participants administered MITT and Trelegy
Timeframe: Up to 1440 days
Time to first hospitalization due to CAP
Timeframe: Up to 1440 days
Number of participants receiving COPD maintenance therapy
Timeframe: Up to 1440 days
Number of participants affected with Coronavirus disease 2019 during follow up
Timeframe: Up to 1440 days
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-29-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Akiyama S, Hashimoto K, Maruoka H, Mizohata H, Oda K, Sasakura N. . Comparison of the Risk of Pneumonia Between Fluticasone Furoate/Umeclidinium/Vilanterol and Multiple-inhaler Triple Therapy in Patients with COPD Using Health Insurance Claims Data: A Post-Authorization Safety Study in Japan. J Clin Med. 2025;14(3): 4697.
https://www.mdpi.com/2077-0383/14/13/4697
PMID: 40649071
DOI: 10.3390/jcm14134697
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate/vilanterol/umeclidinium bromide
Collaborators
Not applicable
Study date(s)
April 2022 to February 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Aged 40 years or older on the index date
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Aged 40 years or older on the index date
- Participants with records of International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD -10) codes for COPD (J42, J43 or J44), one record at the index date and additional 2 records (outpatient visit or hospital admission) in the 360 days look-back period (index date, index date minus [-]360 days).
- At least one record (outpatient visit or hospital admission) with any ICD-10 codes in the 180 days prior to the start date of look-back period (index date -360 days, index date -540 days).
- Two study populations will be set up in Trelegy 100 and MITT users, respectively; COPD participants who started Trelegy 100 or MITT between 22-May-2019 and 5-May-2022 (overall users), and subpopulations of the overall users without any triple therapies in the 360-day look-back period (incident users). Pneumonia occurrence in overall users as well as incident users will be calculated to have good generalizability of study results, since incident users will be a part of overall users. The first use of Trelegy 100 or MITT in the identification period will be included as overall cases. The index date for MITT overall users will be the first prescription date after the launch date of Trelegy 100 (22-May-2019). In the identification of incident users, “any triple therapies in the look-back period” refer to triple therapies with only COPD indication, mixture of COPD and asthma indications, and only asthma indication. Exclusion criteria:
- Participants without any record of COPD diagnosis from 22-May-2019 to 5-May-2022.
- Participants hospitalized within 30 days before the index date by “hospitalization due to CAP”.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
2024-29-02
Actual study completion date
2024-29-02
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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