Last updated: 02/26/2024 12:01:52
Study of treatment patterns among participants with chronic obstructive pulmonary disease (COPD)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Current treatment patterns for individuals with chronic obstructive pulmonary disease (COPD) in Alberta
Trial description: This retrospective cohort study aims to determine patterns of disease-related medication use and health care system utilization among participants with COPD in Alberta. Understanding the current treatment patterns for individuals with COPD may help inform opportunities to improve management and care, and to reduce hospital use and costs within Alberta.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with COPD medication use and treatment patterns
Timeframe: Up to 1 year
Number of participants with health care system utilization
Timeframe: Up to 1 year
Secondary outcomes:
Number of participants with COPD medication use and treatment patterns within 1 year pre-COPD-exacerbation index date
Timeframe: Within 1 year prior to index date
Number of participants with COPD medication use and treatment patterns up to 1 year post-COPD-exacerbation index date
Timeframe: Up to 1 year
Number of participants with health care system utilization within 1 year pre-COPD-exacerbation index date
Timeframe: Within 1 year prior to index date
Number of participants with health care system utilization up to 1 year post-COPD-exacerbation index date
Timeframe: Up to 1 year
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-05-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Stickland MK, Martins KJB, Sharpe H, Vu NK, Bhutani M, Walker BL, Williamson T, Bohlouli S, Richer L, Klarenbach SW. Medication use of Canadians with chronic obstructive pulmonary disease: a cohort study. BMJ Open Respir Res. 2023 Dec 12;10(1):e002083
DOI: 10.1136/bmjresp-2023-002083
PMID: 10729181
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate
Collaborators
Dr. Lawrence Richer, University of Alberta, Canada
Study date(s)
August 2020 to July 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
- Greater than or equal to (>=) 1 hospitalization for COPD or >=1 physician billing claim for COPD on or before 31-Mar-2017.
- >=35 years of age when the hospitalization for COPD or physician billing claim for COPD occurred.
- COPD diagnosis date (i.e. date of COPD incidence) occurred between 1-Apr-2016 and 31-Mar-2017 (i.e. within 1-year before the index date of 31-Mar-2017). COPD diagnosis date is defined as having no hospitalizations for COPD or physician billing claims for COPD within 5-years (as far back as 1-Apr-2011) before the first hospitalization date or physician billing claim for COPD in those individuals with at least 5 years of AHCIP coverage before the incidence year.
Inclusion and exclusion criteria
Inclusion criteria:
- Greater than or equal to (>=) 1 hospitalization for COPD or >=1 physician billing claim for COPD on or before 31-Mar-2017.
- >=35 years of age when the hospitalization for COPD or physician billing claim for COPD occurred.
- Had the Alberta Health Care Insurance Plan (AHCIP) coverage between 1-Apr-2015 and 31-Mar-2018.
- For sub-cohort:
- Experienced a COPD exacerbation between 1-Apr-2017 and 31-Mar-2018. Severe COPD exacerbations are defined as a hospital admission for COPD (ICD-10-CA J41, J42, J43 or J44 occurring in the most responsible diagnostic field). Respiratory-related hospitalizations, not including COPD (ICD-10-CA J00-J99, excluding J41, J42, J43 and J44 occurring in the most responsible diagnostic field) will also be considered. Moderate COPD exacerbations are defined as a COPD claim plus a prescription dispensation for short-course antibiotics and/or systemic corticosteroids within 7-days of that claim. Short-course antibiotics and/or systemic corticosteroids are defined as a prescription with the number of days of supply less than or equal to (<=) 21 days. To differentiate between two separate moderate COPD exacerbations (i.e. COPD claim plus a prescription dispensation for short-course antibiotics and/or systemic corticosteroids within 7-days of that claim), the prescription dispensations are required to be greater than (>) 14 days apart. The first exacerbation occurring between 1-Apr-2017 and 31-Mar-2018 will be considered the COPD exacerbation index date.
- Had AHCIP coverage up to 31-Mar-2019.
Exclusion criteria:
- COPD diagnosis date (i.e. date of COPD incidence) occurred between 1-Apr-2016 and 31-Mar-2017 (i.e. within 1-year before the index date of 31-Mar-2017). COPD diagnosis date is defined as having no hospitalizations for COPD or physician billing claims for COPD within 5-years (as far back as 1-Apr-2011) before the first hospitalization date or physician billing claim for COPD in those individuals with at least 5 years of AHCIP coverage before the incidence year.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
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
Other
Actual primary completion date
2021-05-07
Actual study completion date
2021-05-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website