Pulmonary Disease, Chronic ObstructiveEBISUNCT05219630
Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 17 sites in Japan.
Trial summary
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12-weeks in duration, the initial 4-week period will be used to assess immediate onset of benefits while the full study length will serve to demonstrate… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 106 participants
- Where
- 17 sitesJapan
- Study dates
- 16 May 2022to 30 May 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Around 15 sites across Japan will participate in the study. At each site, the investigators (physicians) will enroll adult patients without asthma history with COPD who initiates BGF pMDI as per the physicians' decision and during an outpatient visit at the in the clinics/hospitals.
Who may be able to join
- Male or female patients aged ≥40 years old at study entry
- Patients diagnosed with COPD (based on post-bronchodilator forced expiratory volume 11/flow volume curve percent predicted forced (FEV1/FVC)<70% in the past and current or former smokers with a smoking history of ≥10 pack-years in the past)
- Patients who is on the new prescription of BGF pMDI 320/18/9.6µg twice daily as per the physician's decision, at baseline
- Patients with CAT≥10 at study entry
- Patients who are capable to fill PROs physically and/or mentally as judged by investigators
- Patients who provide written informed consent prior to the study entry
Who cannot join
- Patients diagnosed as asthma by investigator's judgement at and/or before study entry
- Patients who participated in any interventional clinical studies and/or any relevant studies (quality of life (QoL) and respiratory researches) during the 12 weeks before the study entry and/or during this study
- Patients who used ICS+LABA+LAMA therapy including open triple and closed triple before the study entry
- Patients with history of exacerbation during 4 weeks before the study entry
- Patients with very severe comorbidities or status which would impact on QoL evaluation judged by investigators (e.g., heart failure, malignancy, receiving home oxygen therapy, pneumonia)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Research Site
Chūō, Tokyo
Research Site
Fukui
Research Site
Fukuoka
Research Site
Hiroshima
Research Site
Kagoshima
Research Site
Kanazawa, Ishikawa-ken
Research Site
Kashihara, Nara
Research Site
Kurume, Fukuoka
Research Site
Matsusaka, Mie-ken
Research Site
Miyazaki
Research Site
Nagoya, Aichi-ken
Research Site
Ōita
Research Site
Osaka
Research Site
Seto, Aichi-ken
Research Site
Takamatsu, Kagawa-ken
Research Site
Tōon, Ehime
Research Site
Tsuchiura, Ibaraki
About this study
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12-weeks in duration, the initial 4-week period will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response.
Study design:
Read more
This is a 12-week, multi-center, prospective observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by the physicians in their routine clinical care will be consecutively invited for this study. Investigators (physicians) make screening their patients prior to the study entry and make informed consent explanation at their usual visit timing to the all eligible patients. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice and collect the data at baseline, at week 4 and week 12.
Data Source(s):
The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice
Statistical Analysis:
All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.
Read the detailed description
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12 weeks in duration, the initial 4 weeks will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response. To help contextualize the study result, KRONOS data will be referred where applicable.
Study Design:
This is a 12-week, prospective, multi-center, observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by physician in their routine clinical care will be consecutively invited for this study.
The day of the initiation of BGF pMDI treatment is called baseline, and the timing of fulfilling the eligibility criteria at baseline day is called the study entry.
Investigators (physicians) make screening their candidate patients who will be on the new prescription of BGF pMDI prior to the study entry and make explanation on informed consent at their usual visit timing. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice, and collect the data at baseline, at week 4 [Week 3 (Day 21) to Week 7 (Day 49)] and week 12 [Week 10 (Day 70) to Week 14 (Day 98)].
Data Source(s):
The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice
Statistical Analysis:
All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, PRO, BGF pMDI, CAT, RWD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean changes from baseline in the CAT scores (total score) over week 12
CAT scores will be analysed using a linear model including timepoint (baseline, post-baseline). Mean of available CAT scores over week 4 to 12 will be used as post-baseline in this analysis. Based on the linear model, contrast will be used to estimate the mean changes from baseline over 12 weeks, its 2-sided 95% confidence interval and p-value.
Measured: 12 weeks
Secondary outcomes (3)
Mean changes from baseline in the SGRQ scores (total score) over week 12
SGRQ scores will be analysed using a linear model including timepoint (baseline, post-baseline). Mean of available SGRQ scores over week 4 to 12 will be used as post-baseline in this analysis. Based on the linear model, contrast will be used to estimate the mean changes from baseline over 12 weeks, its 2-sided 95% confidence interval and p-value.
Measured: 12 weeks
Mean changes from baseline in the SGRQ scores (total score) at week 4 and 12
SGRQ scores will be analysed using mixed model for repeated measures (MMRM) including timepoint (baseline, week 4, week 12). For week 4 and 12 timepoints, available data closest to the target timepoint will be used in this analysis. This model account for within-patient correlation, i.e., the non-independence of repeated measures within a same patient. Unstructured covariance structure will be assumed for the within-subject covariance. Based on the MMRM, contrasts will be used to estimate the mean changes from baseline at week 4 and 12, their 2-sided 95% confidence interval and p-value.
Measured: 12 weeks
To assess the achievement of MCID of SGRQ at 4 and 12 weeks from the initiation of BGF pMDI in COPD patients
The number and proportion of patients who achieved changes from baseline greater than or equal to MCID in SGRQ scores (i.e., changes from baseline in SGRQ scores ≥4) at each timepoint will be summarized. The exact 95% confidence interval for the single proportion will also be presented.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start16 May 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219630
- Sponsor's protocol ID
- D5980R00033
- Acronym
- EBISU
- Status last verified
- Apr 2024
- First submitted
- 21 Jan 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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/studies via the request portal. All request 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.
Publications
Muro S, Hozawa S, Sugiura H, Yoshida Y, Makita N, Kato Y, Hirai T, Nishida K, Kawayama T. Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study. Respir Investig. 2025 Sep;63(5):726-733. doi: 10.1016/j.resinv.2025.05.007. Epub 2025 Jun 11.
PubMed 40513294
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)
- ClinicalTrials.gov ID
- NCT05219630
- Acronym / sponsor ID
- EBISU / D5980R00033
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, PRO, BGF pMDI, CAT, RWD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 2 Feb 2022 (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.
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12-weeks in duration, the initial 4-week period will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response.
Study design:
This is a 12-week, multi-center, prospective observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by the physicians in their routine clinical care will be consecutively invited for this study. Investigators (physicians) make screening their patients prior to the study entry and make informed consent explanation at their usual visit timing to the all eligible patients. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice and collect the data at baseline, at week 4 and week 12.
Data Source(s):
The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice
Statistical Analysis:
All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.
Detailed description
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12 weeks in duration, the initial 4 weeks will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response. To help contextualize the study result, KRONOS data will be referred where applicable.
Study Design:
This is a 12-week, prospective, multi-center, observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by physician in their routine clinical care will be consecutively invited for this study.
The day of the initiation of BGF pMDI treatment is called baseline, and the timing of fulfilling the eligibility criteria at baseline day is called the study entry.
Investigators (physicians) make screening their candidate patients who will be on the new prescription of BGF pMDI prior to the study entry and make explanation on informed consent at their usual visit timing. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice, and collect the data at baseline, at week 4 [Week 3 (Day 21) to Week 7 (Day 49)] and week 12 [Week 10 (Day 70) to Week 14 (Day 98)].
Data Source(s):
The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice
Statistical Analysis:
All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Around 15 sites across Japan will participate in the study. At each site, the investigators (physicians) will enroll adult patients without asthma history with COPD who initiates BGF pMDI as per the physicians' decision and during an outpatient visit at the in the clinics/hospitals.
Key inclusion criteria (6 listed)
- Male or female patients aged ≥40 years old at study entry
- Patients diagnosed with COPD (based on post-bronchodilator forced expiratory volume 11/flow volume curve percent predicted forced (FEV1/FVC)<70% in the past and current or former smokers with a smoking history of ≥10 pack-years in the past)
- Patients who is on the new prescription of BGF pMDI 320/18/9.6µg twice daily as per the physician's decision, at baseline
- Patients with CAT≥10 at study entry
- Patients who are capable to fill PROs physically and/or mentally as judged by investigators
Key exclusion criteria (5 listed)
- Patients diagnosed as asthma by investigator's judgement at and/or before study entry
- Patients who participated in any interventional clinical studies and/or any relevant studies (quality of life (QoL) and respiratory researches) during the 12 weeks before the study entry and/or during this study
- Patients who used ICS+LABA+LAMA therapy including open triple and closed triple before the study entry
- Patients with history of exacerbation during 4 weeks before the study entry
- Patients with very severe comorbidities or status which would impact on QoL evaluation judged by investigators (e.g., heart failure, malignancy, receiving home oxygen therapy, pneumonia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean changes from baseline in the CAT scores (total score) over week 12
Time frame: 12 weeks
CAT scores will be analysed using a linear model including timepoint (baseline, post-baseline). Mean of available CAT scores over week 4 to 12 will be used as post-baseline in this analysis. Based on the linear model, contrast will be used to estimate the mean changes from baseline over 12 weeks, its 2-sided 95% confidence interval and p-value.
3 secondary outcomes
Mean changes from baseline in the SGRQ scores (total score) over week 12
Time frame: 12 weeks
Mean changes from baseline in the SGRQ scores (total score) at week 4 and 12
Time frame: 12 weeks
To assess the achievement of MCID of SGRQ at 4 and 12 weeks from the initiation of BGF pMDI in COPD patients
Time frame: 12 weeks
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 23 Apr 2024.
- Derived from this study: PubMed 40513294Muro S, Hozawa S, Sugiura H, Yoshida Y, Makita N, Kato Y, Hirai T, Nishida K, Kawayama T. Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study. Respir Investig. 2025 Sep;63(5):726-733. doi: 10.1016/j.resinv.2025.05.007. Epub 2025 Jun 11.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request 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.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 17 sites in Japan.
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 5 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. 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 changes from baseline in the CAT scores (total score) over week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219630, which also lists 1 linked publication.
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 23 Apr 2024.