Last updated: 04/11/2025 11:20:22

Assessing effectiveness outcomes in COPD patients switching from multiple to single inhaler triple therapy in a real-world setting (Japan)

GSK study ID
217616
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assessing effectiveness outcomes in COPD patients switching from multiple to single inhaler triple therapy in a real-world setting
Trial description: The purpose of the study is to compare the effectiveness outcomes prior to and following a switch from Multiple Inhaler Triple Therapy (MITT) to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), evaluated by Chronic Obstructive Pulmonary Disease (COPD) exacerbation rates, Health Care Resource Utilization (HCRU) and associated direct medical costs, and medication adherence. The study will be conducted using the Japanese Medical Data Vision (MDV) hospital claims database. . This study includes baseline period, during which baseline demographics and clinical characteristics will be observed. Baseline period is defined as 12 months prior to the index date. The minimum follow-up period for inclusion in the study will be 6 months. For the primary analysis patients must have at least 6 months of cumulative MITT in the 12 months prior to index, followed by a pharmacy claim for Single Inhaler Triple Therapy (SITT) within the index period. The index date will be defined as the first / earliest date of FF/UMEC/VI initiation, SITT within the indexing period of 1st May 2019 to 28th February 2022, following a period of MITT use.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of participants with COPD exacerbations in the 6 months prior to and following switch from MITT to SITT

Timeframe: Up to 6 months

Rate of COPD exacerbations among participants in the 6 months prior to and following switch from MITT to SITT

Timeframe: Up to 6 months

Secondary outcomes:

Rate of COPD exacerbations among participants in the 6 months prior to and following switch from MITT to SITT while on MITT

Timeframe: Up to 6 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-31-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Requena G, Mizukami A, Ford A, Camidge L, Yarita M, Hashimoto K, et al. . Effectiveness of switching from multiple-inhaler to once-daily single-inhaler triple therapy in patients with COPD in a real-world setting in Japan. Int J Chron Obstruct Pulmon Dis. 2025;2025(20): 565-580. doi:10.2147/COPD.S478455 https://www.dovepress.com/articles.php?article_id=100926 PMID: 40078928 DOI: 10.2147/COPD.S478455
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate/vilanterol/umeclidinium bromide
Collaborators
Not applicable
Study date(s)
August 2023 to August 2023
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
40 Years - NA Not applicable
Accepts healthy volunteers
No
  • At least one inpatient diagnosis and / or at least two outpatient diagnoses (in separate calendar months) of COPD [International Classification of Diseases version 10 (ICD-10) of J42, J43 or J44] at any time in the patient’s medical history prior to and including the index month
  • At least 12 months of continuous enrolment prior to the index date (excluding the index date)
  • One or more diagnostic code (ICD-10) of any medical conditions incompatible with a COPD diagnosis at any time in the patient’s medical history prior to the month of index and including index month, i.e., conditions that are related to lung or bronchial developmental anomalies, degenerative processes (cystic fibrosis, pulmonary fibrosis), pulmonary resection or other significant respiratory disorders other than COPD that can interfere with clinical COPD diagnosis or substantially change the natural history of the disease.
  • One or more pharmacy claim observable for any SITT prescription prior to index
Inclusion and exclusion criteria
Inclusion criteria:
  • At least one inpatient diagnosis and / or at least two outpatient diagnoses (in separate calendar months) of COPD [International Classification of Diseases version 10 (ICD-10) of J42, J43 or J44] at any time in the patient’s medical history prior to and including the index month
  • At least 12 months of continuous enrolment prior to the index date (excluding the index date)
  • At least 6 calendar months of data availability following, but not including, the index calendar month up to the earlier of: last/ most recent diagnosis or medical claim record, or 31st August 2022 (i.e. end of study period).
  • At least 1 pharmacy claim observable of FF/UMEC/VI within the indexing period
  • At least 1 day of MITT use (i.e. overlap of all triple therapy components) within the 6 months prior to the index date
  • At least 6 months (180 days) of cumulative use of MITT, prior to index date (FF/UMEC/VI initiation)
Exclusion criteria:
  • One or more diagnostic code (ICD-10) of any medical conditions incompatible with a COPD diagnosis at any time in the patient’s medical history prior to the month of index and including index month, i.e., conditions that are related to lung or bronchial developmental anomalies, degenerative processes (cystic fibrosis, pulmonary fibrosis), pulmonary resection or other significant respiratory disorders other than COPD that can interfere with clinical COPD diagnosis or substantially change the natural history of the disease.
  • One or more pharmacy claim observable for any SITT prescription prior to index

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2023-31-08
Actual study completion date
2023-31-08

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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