Clinical trial NCT06511193: Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]
Official title: Chronicling the COPD Patient Journey and Change in Impact of a Single Inhaler Combination Therapy on COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF](CHRONICLES COPD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD;
readmissions;
maintenance therapy;
triple therapy;
real-world evidence;
mortality;
cardiopulmonary events,
exacerbations
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Asthma Research Group Inc.
name: University Health Network, Toronto
First posted: 2024-07-19
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe COPD who are eligible for BGF therapy may be enrolled by physicians in primary care setting. The decision to start treatment with BGF must be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision to prescribe BGF must be independent of enrolment into the study, is determined by the treating physician and should be taken according to the standard of current best medical practice and national guidelines.

Brief summary: The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol \[BGF\] in a real-world setting.

Detailed description: This is a prospective, open label, non-interventional, single network of clinical practice centers study that will be conducted in routine clinical care in the pulmonary/ primary care practitioner (PCP) care setting in Ontario, Canada. Eligible patients will be enrolled into the study only following the treating physician's decision and patient agreement to initiate treatment with BGF. Patients will be observed for up to 6 months post-treatment initiation with BGF.

Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of COPD
* COPD patients in the Best Care Network who have a CAT score \>=10
* Age \>=35 at time of enrolment
* Minimum 12-month recorded prior medical history for patients
* Physician decision and patient agreement to initiate treatment with Breztri based on routine care (and in accordance with label and reimbursement criteria)
* Ability to read English and to provide consent to inclusion in the study

Exclusion Criteria:

* Diagnosis of asthma
* Dementia or other health issues related to memory
* Inability to use inhalers
* COPD due to documented α-1 antitrypsin deficiency
* Previous treatment with triple fixed-dose combination therapy in 12 months prior to screening visit
* Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment
* Pregnancy or lactation period
* Participation in an ongoing clinical interventional or observational trial for another COPD medication (or completed another trial within last 30 days of initiating BGF)
* Patient self-reporting or a physician record with an active COVID-19 infection at time of enrolment or hospitalized due to COVID-19 infection in the last 60 days
* Previous enrolment in this study

Primary outcomes:
measure: Mean change from baseline in the COPD Assessment Test (CAT) score
timeFrame: 12 weeks after treatment initiation
Secondary outcomes:
measure: Demographic and clinical characteristics at baseline
timeFrame: At baseline
measure: Change from baseline in CAT score after 24 weeks of treatment
timeFrame: 24 weeks from treatment initiation
measure: Change in patient quality of life as measured by EQ-5D-5L at 12 and 24 weeks post-treatment initiation
timeFrame: 12 and 24 weeks after treatment initiation
measure: Change in measures of sleep quality using CASIS (COPD and Asthma Sleep Impact Scale) at weeks 12 and 24
timeFrame: 12 and 24 weeks of treatment initiation
measure: Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline
timeFrame: 12 weeks treatment compared to baseline
measure: The annualized rate of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit
timeFrame: Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months))
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: Best Care Network (Asthma Research Group Windsor Essex County INC) 1641 Provincial Road Windsor, Ontario, N8W 5V7 Canada
name: Christopher James Licskai, MD
role: PRINCIPAL_INVESTIGATOR
References: