Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI) (EBISU)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Japan
  • Fukui, Japan
    • Research Site
  • Fukuoka, Japan
    • Research Site
  • Hiroshima, Japan
    • Research Site
  • Kagoshima, Japan
    • Research Site
  • Miyazaki, Japan
    • Research Site
  • Oita, Japan
    • Research Site
  • Osaka, Japan
    • Research Site
  • Aichi
    • Nagoya, Aichi, Japan
      • Research Site
    • Seto, Aichi, Japan
      • Research Site
  • Ehime
    • Toon, Ehime, Japan
      • Research Site
  • Fukuoka
    • Kurume, Fukuoka, Japan
      • Research Site
  • Ibaraki
    • Tsuchiura, Ibaraki, Japan
      • Research Site
  • Ishikawa
    • Kanazawa, Ishikawa, Japan
      • Research Site
  • Kagawa
    • Takamatsu, Kagawa, Japan
      • Research Site
  • Mie
    • Matsusaka, Mie, Japan
      • Research Site
  • Nara
    • Kashihara, Nara, Japan
      • Research Site
  • Tokyo
    • Chuo, Tokyo, Japan
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

1. Male or female patients aged ≥40 years old at study entry
2. 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)
3. Patients who is on the new prescription of BGF pMDI 320/18/9.6µg twice daily as per the physician's decision, at baseline
4. Patients with CAT≥10 at study entry
5. Patients who are capable to fill PROs physically and/or mentally as judged by investigators
6. Patients who provide written informed consent prior to the study entry

Exclusion Criteria:

1. Patients diagnosed as asthma by investigator's judgement at and/or before study entry
2. 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
3. Patients who used ICS+LABA+LAMA therapy including open triple and closed triple before the study entry
4. Patients with history of exacerbation during 4 weeks before the study entry
5. 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: COPD, PRO, BGF pMDI, CAT, RWD
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D5980R00033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No