Research Site
Windsor, Ontario, N8W 5V7, Canada
NCT Number: NCT06511193
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.
Looking for future studies?
Notify Me35 year–130 year
All sexes
Observational
Windsor, Ontario, N8W 5V7, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria
Time frame: 12 weeks after treatment initiation
To estimate the change in COPD health status in patients initiating BGF after 12 weeks
Time frame: At baseline
To describe the demographic and clinical characteristics of patients in the study
Time frame: 24 weeks from treatment initiation
To estimate the change in COPD health status after 24 weeks from treatment initiation
Time frame: 12 and 24 weeks after 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 of treatment initiation
To estimate change in sleep quality following introduction of BGF
Time frame: 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: Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months))
To describe and compare the rate of moderate and severe exacerbations
AstraZeneca
Industry
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)
Acronym: CHRONICLES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06040086
Chronic Disease, Chronic Obstructive Pulmonary Disease (COPD)
Birmingham, Alabama, United States
View Trial DetailsNCT01917331
Chronic Disease, Chronic Obstructive Pulmonary Disease (COPD)
Szeged, Hungary
View Trial DetailsNCT06897748
Chronic Disease, Chronic Obstructive Pulmonary Disease (COPD)
Aramil, Russia
View Trial DetailsNCT04119934
Behavior, Chronic Disease
Toronto, Ontario, Canada
View Trial Details