Chronic Obstructive Pulmonary Disease (COPD)CHRONICLESNCT06511193
Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 130 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Budenoside/Glycopyrronium/Formoterol
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2024to 5 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- Budenoside/Glycopyrronium/Formoterol
- Keywords
- COPD;, readmissions;, maintenance therapy;, triple therapy;, real-world evidence;, mortality;, cardiopulmonary events,, exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budenoside/Glycopyrronium/FormoterolDrug
Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria
| Study group | Role | What they receive |
|---|---|---|
| Budenoside/Glycopyrronium/Formoterol | Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria Receives: Drug: Budenoside/Glycopyrronium/Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks after treatment initiation
Secondary outcomes (6)
Demographic and clinical characteristics at baseline
To describe the demographic and clinical characteristics of patients in the study
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start17 Sep 2024
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asthma Research Group Inc., University Health Network, Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511193
- Sponsor's protocol ID
- D5980R00105
- Acronym
- CHRONICLES
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06511193
- Acronym / sponsor ID
- CHRONICLES / D5980R00105
- Keywords
- COPD;, readmissions;, maintenance therapy;, triple therapy;, real-world evidence;, mortality;, cardiopulmonary events,, exacerbations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Asthma Research Group Inc., University Health Network, Toronto
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Budenoside/Glycopyrronium/Formoterol | – | Drug: Budenoside/Glycopyrronium/FormoterolPatients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria |
Who may qualify
- Ages
- 35 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budenoside/Glycopyrronium/FormoterolPatients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria | Drug | Budenoside/Glycopyrronium/Formoterol |
Primary outcome
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
6 secondary outcomes
Demographic and clinical characteristics at baseline
Time frame: At baseline
Change from baseline in CAT score after 24 weeks of treatment
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
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
Time frame: 12 and 24 weeks of treatment initiation
Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline
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
Time frame: Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: 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.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in the COPD Assessment Test (CAT) score (time frame: 12 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.