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TORES: Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04536402
Collaborator
(none)
3,050
Enrollment
30
Locations
21.3
Anticipated Duration (Months)
101.7
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is an observational, multicenter, prospective, single arm study. The objective of this study is to evaluate the safety of Breztri® Aerosphere® in Chinese patients with COPD in real world clinical practice. The study will enrol approximately 3,050 subjects from about 42 sites around China and followed up for 12 weeks.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is an observational, multicenter, prospective, single arm study. 3,050 subjects who have been prescribed and have planned to take at least one inhalation of BGF MDI will be enrolled into the study

    This is an observational study. BGF MDI treatment will be studied through non-interventional approach. It will be carried out under routine clinical practice and the start or end of BGF MDI and other concomitant treatment will be determined by subjects' treating physicians.

    Eligible subjects will be consecutively enrolled in this study at the time they routinely visit their physician and consent to participate in the study. After enrolled successfully, baseline variables will be collected at V1. Subjects will be followed up every 4 weeks after baseline for a total duration of 12 weeks or until study discontinuation, whichever occurs first. V1 and V2 will be followed up by on-site visit and V3 and V4 will be followed up by telephone call visit. For subjects who remain on study drug throughout the study (i.e., complete 4 Visits), a follow up telephone call will be performed at 14 days after the last visit to collect safety information. For subjects who has an Early Discontinuation, 14 days follow up is needed for AE collecting after the discontinuation. For subjects who had been hospitalized during the first 4 weeks of follow-up due to one or more acute exacerbations of COPD, a follow up telephone call will be performed at 28 days after the last visit to collect safety information.

    The subjects will be recruited from qualified hospitals. Safety and effectiveness data will be collected following enrollment in the study. Medical records, PROs (COPD Assessment Test [CAT], St. George's Respiratory Questionnaire [SGRQ], Aerosphere Delivery Technology Metered Dose Inhaler Preference Questionnaire [AMPQ], Patient Global Impression of Change [PGIC]) will be the data source in this study.

    Primary endpoint will be the incidence of AEs and SAEs in purpose of monitoring the safety profile of BGF MDI.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3050 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Multi-centre, Prospective, Observational Post-Authorization Safety Study to Evaluate the Safety Profile of Budesonide/Glycopyrrolate/Formoterol MDI in Chinese Patients With COPD in Routine Clinical Practice
    Actual Study Start Date :
    Mar 22, 2021
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of all AEs /SAEs [2022-12-30]

      To evaluate the safety profile after BGF MDI treatment in Chinese COPD patients

    Secondary Outcome Measures

    1. Change from baseline in CAT score [2022-12-30]

      To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs)

    2. Change from baseline in SGRQ score [2022-12-30]

      To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs)

    3. ADT MDI preference questionnaire (AMPQ) [2022-12-30]

      To describe patient preference for the Aerosphere Delivery Technology

    4. Patient global impression of change (PGIC) [2022-12-30]

      To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs)

    5. Mean total COPD cost including the direct and indirect COPD cost [2022-12-30]

      To assess total direct and indirect COPD cost

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Give their signed written informed consent to participate

    • Age: 18 and above

    • Chinese, Female or male

    • Patient with diagnosis of COPD as defined by clinicians

    • Subjects who have been prescribed and have planned to take at least one inhalation of Budesonide/Glycopyrrolate/Formoterol MDI based on physician's decision.

    Exclusion Criteria:

    Subjects who meet any of the following criteria will not be able to enter the study：

    • Subjects who are currently involved in any other interventional studies.

    • Drug Allergy: Subjects who have a history of hypersensitivity to formoterol or any other β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

    • Subjects who received investigational drug treatment within 30 days prior to Visit 1.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Beijing China 100070
    2 Research Site Beijing China
    3 Research Site Changzhi China 046000
    4 Research Site Chengdu China 610016
    5 Research Site Guangzhou China 510120
    6 Research Site Guangzhou China 510150
    7 Research Site Guangzhou China 510620
    8 Research Site Haikou China 570311
    9 Research Site Hangzhou China 310005
    10 Research Site Jinan China 250012
    11 Research Site Jinhua China 321000
    12 Research Site Jinzhong China 030600
    13 Research Site Linhai China 317000
    14 Research Site Mianyang China 621000
    15 Research Site Nanjing China 211100
    16 Research Site Shanghai China 200433
    17 Research Site Shenzhen China 518039
    18 Research Site Shenzhen China 518055
    19 Research Site Shenzhen China 518100
    20 Research Site Suqian China 223800
    21 Research Site Taizhou China 318000
    22 Research Site Urumqi China 830054
    23 Research Site Weifang China 261041
    24 Research Site Wuxi China 214002
    25 Research Site Xi'an China 710000
    26 Research Site Xian China 710100
    27 Research Site Xin Xiang China
    28 Research Site Yangquan China 045000
    29 Research Site Zhengzhou China 451100
    30 Research Site Zibo China

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Yongchang Sun, Peking Universicy Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04536402
    Other Study ID Numbers:
    • D5980R00016
    First Posted:
    Sep 2, 2020
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    COPD
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Aug 3, 2022