Tracking changes in COPD symptoms and quality of life after starting a new treatment
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)
This study is testing how a new treatment called BGF affects symptoms and quality of life for people with COPD over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 35 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 1 site (Windsor, Ontario) |
| Trial ID | NCT06511193 on ClinicalTrials.gov |
What this trial studies
The CHRONICLES study aims to observe the effects of Budenoside/Glycopyrronium/Formoterol (BGF) on patients with Chronic Obstructive Pulmonary Disease (COPD) over a six-month period in a real-world clinical setting. This prospective, open-label, non-interventional study will enroll patients from a network of clinical practice centers in Ontario, Canada, following their physician's decision to initiate treatment. Participants will be monitored for changes in clinical outcomes and patient-reported symptoms after starting BGF therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 35 and older with a physician diagnosis of COPD and a CAT score of 10 or higher.
Not a fit: Patients with asthma, recent COPD exacerbations, or those unable to use inhalers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of BGF in improving COPD symptoms and quality of life.
How similar studies have performed: Other studies have shown success with similar observational approaches in COPD management, indicating potential for meaningful findings in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Windsor, Ontario
- Research Site — Windsor, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Christopher James Licskai, MD — Best Care Network (Asthma Research Group Windsor Essex County INC) 1641 Provincial Road Windsor, Ontario, N8W 5V7 Canada
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.