An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 1 site in Canada. Open to participants aged 35 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by AstraZeneca · Observational
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 152 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria
Drug: Budenoside/Glycopyrronium/Formoterol
Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria
Mean change from baseline in the COPD Assessment Test (CAT) score
To estimate the change in COPD health status in patients initiating BGF after 12 weeks
Time frame: 12 weeks after treatment initiation
Demographic and clinical characteristics at baseline
To describe the demographic and clinical characteristics of patients in the study
Time frame: At baseline
Change from baseline in CAT score after 24 weeks of treatment
To estimate the change in COPD health status after 24 weeks from treatment initiation
Time frame: 24 weeks from treatment initiation
Change in patient quality of life as measured by EQ-5D-5L at 12 and 24 weeks post-treatment initiation
To estimate the change in patient quality of life after 12 and 24 weeks of treatment initiation
Time frame: 12 and 24 weeks after treatment initiation
Change in measures of sleep quality using CASIS (COPD and Asthma Sleep Impact Scale) at weeks 12 and 24
To estimate change in sleep quality following introduction of BGF
Time frame: 12 and 24 weeks of treatment initiation
Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline
To describe the Responder Rate based on the CAT after 12 weeks of initiating treatment with BGF
Time frame: 12 weeks treatment compared to baseline
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
To describe and compare the rate of moderate and severe exacerbations
Time frame: Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months))
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
AstraZeneca