Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
None listed
Sponsors
Philip Morris Products S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with any healthcare encounter records in the Tokushukai Medical Database -Patients with a record of Index Event (first COPD-related hospitalization between the 1st of May 2016 and the 31st of December 2022) -Age 40 year or older at the time of the Index Event -Patients of any gender -Patients or relatives who are able to understand the information provided in the ICF and have signed it.
Exclusion criteria
Exclusion criteria: -Tobacco industry employees or their first-degree relatives -Employees of Philip Morris International (PMI) and its affiliate companies, Tokushukai Medical Corporation, 3H Medi Solution, or Syneos Health Clinical K.K. -Patients who have had five or more COPD-related hospitalizations in the 12 months prior to the Index Event -Never smokers (this population was excluded because the prevalence of never smoking is extremely low among COPD patient population). -Patients having any of the following diseases prior to the Index Event: bronchiectasis, active tuberculosis (defined as a tuberculosis diagnosis in the 12 months prior to Index Event), cystic fibrosis, pulmonary fibrosis, pulmonary embolism, lung cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time from Index Event to a first subsequent COPD-related hospitalization or all-cause mortality between comparable groups of exclusive HTP users and exclusive CIG smokers. -Index Event defined as a first COPD-related hospitalization between 1st May 2016 and 31st December 2022. -The composite endpoint defined as (whichever comes first): -First subsequent COPD-related hospitalization -All-cause mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the time from Index Event to all-cause mortality between comparable groups of i) exclusive HTP users versus exclusive CIG smokers, ii) exclusive HTP users versus former smokers, and iii) exclusive HTP users versus dual users of CIG and HTP. Endpoint: -All-cause mortality 2.To compare the time from Index Event to a first pneumonia-related hospitalization between comparable groups of i) exclusive HTP users versus exclusive CIG smokers, ii) exclusive HTP users versus former smokers, and iii) exclusive HTP users versus dual users of CIG and HTP. Endpoint: -Pneumonia-related hospitalization 3.To compare the number and rate of recurrent COPD-related hospitalizations and all-cause hospitalization per year accounting for death as competing risk from Index Event by comparable tobacco exposure groups (exclusive HTP users, dual users of HTP and CIG, and former smokers). Endpoints: -Rate and number of COPD-related hospitalizations for each year post-index during the entire observation period -All-cause hospitalizations for each year post-index during the entire observation period 4.To compare the time from Index Event to the composite endpoint defined above (first subsequent COPD-related hospitalization or all-cause mortality) between comparable groups of i) exclusive HTP users versus former smokers and ii) exclusive HTP users versus dual users of CIG and HTP. Endpoint: Composite endpoint defined as (whichever comes first): -First subsequent COPD-related hospitalization -All-cause mortality 5.To evaluate whether the time from Index Event to a first subsequent COPD-related hospitalization or all-cause mortality for exclusive HTP users vs exclusive CIG smokers varies for exclusive HTP users by the number of years of switching (<1 year, 1-3 years, >3 years). Endpoint: Composite endpoint defined as (whichever comes first): -First subsequent COPD-related hospitalization -All-cause mortality | — |
Countries
Japan
Contacts
Public ContactTakashi Sato
Syneos Health Clinical K.K. Clinical Operations/Real World and Late Phase
Outcome results
None listed