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Completed

NCT Number: NCT06511193

Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]

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.

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Key information

Age range

35 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Windsor, Ontario, N8W 5V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budenoside/Glycopyrronium/Formoterol

Drug

Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria

Primary outcomes

  1. Mean change from baseline in the COPD Assessment Test (CAT) score

    Time frame: 12 weeks after treatment initiation

    To estimate the change in COPD health status in patients initiating BGF after 12 weeks

Secondary outcomes

  1. Demographic and clinical characteristics at baseline

    Time frame: At baseline

    To describe the demographic and clinical characteristics of patients in the study

  2. Change from baseline in CAT score after 24 weeks of treatment

    Time frame: 24 weeks from treatment initiation

    To estimate the change in COPD health status after 24 weeks from treatment initiation

  3. Change in patient quality of life as measured by EQ-5D-5L at 12 and 24 weeks post-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

  4. Change in measures of sleep quality using CASIS (COPD and Asthma Sleep Impact Scale) at weeks 12 and 24

    Time frame: 12 and 24 weeks of treatment initiation

    To estimate change in sleep quality following introduction of BGF

  5. Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline

    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

  6. 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

    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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Asthma Research Group Inc.
  • University Health Network, Toronto

Registry information

Official study 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)

Acronym: CHRONICLES

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2024
Registry last updated
Jun 24, 2026

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.

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