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

NCT05219630 | Completed

• 1 other identifier: D5980R00033
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 17

Brief 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 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, PRO, BGF pMDI, CAT, RWD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean changes from baseline in the SGRQ scores (total score) over week 12

  12 weeks

• Mean changes from baseline in the SGRQ scores (total score) at week 4 and 12

  12 weeks

• To assess the achievement of MCID of SGRQ at 4 and 12 weeks from the initiation of BGF pMDI in COPD patients

  12 weeks

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (17)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Seto, Aichi-ken, Japan

Location

Research Site

Tōon, Ehime, Japan

Location

Research Site

Kurume, Fukuoka, Japan

Location

Research Site

Tsuchiura, Ibaraki, Japan

Location

Research Site

Kanazawa, Ishikawa-ken, Japan

Location

Research Site

Takamatsu, Kagawa-ken, Japan

Location

Research Site

Matsusaka, Mie-ken, Japan

Location

Research Site

Kashihara, Nara, Japan

Location

Research Site

Chūō, Tokyo, Japan

Location

Research Site

Fukui, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Hiroshima, Japan

Location

Research Site

Kagoshima, Japan

Location

Research Site

Miyazaki, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Ōita, Japan

Location

Related Publications (1)

• 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.

  PMID: 40513294 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: May 16, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

JP (17)