Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— MARUOfficial title:
Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients-Retrospective Observational Cohort Study
NCT number | NCT03359122 |
Other study ID # | D2287R00123 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 7, 2018 |
Est. completion date | August 20, 2018 |
Verified date | July 2019 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.
Status | Completed |
Enrollment | 10067 |
Est. completion date | August 20, 2018 |
Est. primary completion date | August 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Patients diagnosed with COPD in 2015; 2. Patients had complete hospital visit data available during pre-index 1 year period and post 1 year follow-up; 3. Patients had at least one COPD exacerbation during 1 year prior to the index date; 4. Patients had at least 2 COPD maintenance medication claims during post index 1 year period, as 2 claims are recommended to calculate adherence. Exclusion Criteria: 1. Inability to determine diagnoses from claims; 2. Individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma. |
Country | Name | City | State |
---|---|---|---|
China | Research site | Beijing |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Indicators of COPD control | Number of exacerbations | 2015.01-2016.12 | |
Primary | Health resource utilization | Annual number of inpatient days | 2015.01-2016.12 | |
Primary | Costs of inpatient treatment | Cost of COPD exacerbation inpatient treatment | 2015.01-2016.12 | |
Primary | Health resource utilization | Inpatient visit number | 2015.01-2016.12 | |
Primary | Health resource utilization | Emergency department (ED) visit number | 2015.01-2016.12 | |
Primary | Costs of inpatient treatment | Cost of all-cause inpatient treatment | 2015.01-2016.12 |
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