Last updated: 02/06/2024 17:30:54
Prompt versus delayed initiation of triple therapy 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: Evaluation of Prompt vs Delayed Initiation of Triple Therapy in Chronic Obstructive Pulmonary Disease: Japan
Trial description: This study aims to assess whether prompt versus delayed initiation of triple therapy following a moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is associated with a difference in subsequent AECOPDs, hospital readmissions and healthcare resource use (HCRU)/costs among participants with COPD in Japan.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of subsequent moderate or severe AECOPDs
Timeframe: Up to 12 months prior to index date
Number of exacerbation episodes
Timeframe: Up to 12 months prior to index date
Secondary outcomes:
Time-to-first subsequent AECOPD
Timeframe: Up to 12 months prior to index date
All-cause and COPD-related hospital readmission
Timeframe: At 30, 60 and 90 days
Time-to-first hospital readmission related to all-cause and COPD
Timeframe: At 30, 60 and 90 days
All-cause and COPD-related HCRU and direct medical costs
Timeframe: Up to 12 months prior to index date
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-28-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Akiyama S, Camidge L, Czira A, Hashimoto K, Ishii T, Ismaila A, et al. Benefit of prompt vs delayed initiation of triple therapy following an exacerbation in patients with COPD in Japan: a retrospective cohort study. Int J Chron Obstruct Pulmon Dis.
DOI: 10.2147/COPD.S419119
PMID: 38089540
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2022 to June 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Participant with at least one inpatient diagnosis and/or at least two outpatient diagnoses of COPD (International Classification of Diseases version 10 [ICD-10] of J42, J43 or J44) at age 40 years or above at any time in the participant's medical history.
- Participant with at least one moderate or severe AECOPD on or after 01-Apr-2010 and before 31-Mar-2020. The date of the first/earliest AECOPD event (date of earliest outpatient pharmacy claim for antibiotics (ATB) or systemic corticosteroids (SCS) for moderate AECOPDs, date of discharge for severe AECOPDs) will be defined as the index date.
- Participants with one or more AECOPD (moderate or severe) during the Baseline period.
- Participants with one or more diagnostic code (ICD-10) of any medical conditions incompatible with a COPD diagnosis at any time in the participant's medical history prior to the month of index, 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant with at least one inpatient diagnosis and/or at least two outpatient diagnoses of COPD (International Classification of Diseases version 10 [ICD-10] of J42, J43 or J44) at age 40 years or above at any time in the participant's medical history.
- Participant with at least one moderate or severe AECOPD on or after 01-Apr-2010 and before 31-Mar-2020. The date of the first/earliest AECOPD event (date of earliest outpatient pharmacy claim for antibiotics (ATB) or systemic corticosteroids (SCS) for moderate AECOPDs, date of discharge for severe AECOPDs) will be defined as the index date.
- Participant with at least one pharmacy claim for triple therapy on or within 180 days of the index date.
- Participant with at least one diagnosis or medical claim record in the 12 months prior to the index date, in addition to at least one diagnosis or medical claim record in the 12-18 months prior to the index date.
- Participant at least 12 months of data availability following, and including, the index date up to the earlier of: last/ most recent diagnosis or medical claim record, or 31-Mar-2021 (that is [i.e.] end of study period.
Exclusion criteria:
- Participants with one or more AECOPD (moderate or severe) during the Baseline period.
- Participants with one or more diagnostic code (ICD-10) of any medical conditions incompatible with a COPD diagnosis at any time in the participant's medical history prior to the month of index, 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.
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
2022-28-06
Actual study completion date
2022-28-06
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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