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Chronic Obstructive Pulmonary DiseaseTORESNCT04536402

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

An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 40 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
How many people
3,520 participants
Where
40 sitesChina
Study dates
16 Mar 2021to 8 Nov 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will enroll 3,050 Chinese COPD patients who have been prescribed and have planned to take at least one inhalation of BGF MDI. The decision to start with BGF MDI treatment is independent of this study.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • Research Site

    Beijing, 100070

  • Research Site

    Beijing

  • Research Site

    Changzhi, 046000

  • Research Site

    Chengdu, 610016

  • Research Site

    Chengdu

  • Research Site

    Chifeng

  • Research Site

    Chongqing

  • Research Site

    Guangyuan

  • Research Site

    Guangzhou, 510120

  • Research Site

    Guangzhou, 510150

  • Research Site

    Guangzhou, 510620

  • Research Site

    Haikou, 570311

  • Research Site

    Haikou

  • Research Site

    Haining

  • Research Site

    Hangzhou, 310005

  • Research Site

    Hangzhou

  • Research Site

    Huizhou

  • Research Site

    Jiaxing

  • Research Site

    Jinan, 250012

  • Research Site

    Jinhua, 321000

  • Research Site

    Jinzhong, 030600

  • Research Site

    Mianyang, 621000

  • Research Site

    Nanjing, 211100

  • Research Site

    Nanjing, 223800

  • Research Site

    Shanghai, 200433

  • Research Site

    Shenzhen, 518039

  • Research Site

    Shenzhen, 518055

  • Research Site

    Shenzhen, 518100

  • Research Site

    Taizhou, 317000

  • Research Site

    Taizhou, 318000

  • Research Site

    Weifang, 261041

  • Research Site

    Wuxi, 214002

  • Research Site

    Xi'an, 710000

  • Research Site

    Xi'an, 710100

  • Research Site

    Xinxiang

  • Research Site

    Xinzheng, 451100

  • Research Site

    Yangquan, 045000

  • Research Site

    Yinchuan

  • Research Site

    Zhengzhou

  • Research Site

    Zibo

Other trials in China

About this study

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

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.

Read the 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.

Keywords
COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all AEs /SAEs

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

    Measured: 2022-12-30

Secondary outcomes (5)

  1. Change from baseline in CAT score

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

    Measured: 2022-12-30

  2. Change from baseline in SGRQ score

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

    Measured: 2022-12-30

  3. ADT MDI preference questionnaire (AMPQ)

    To describe patient preference for the Aerosphere Delivery Technology

    Measured: 2022-12-30

  4. Patient global impression of change (PGIC)

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

    Measured: 2022-12-30

  5. Mean total COPD cost including the direct and indirect COPD cost

    To assess total direct and indirect COPD cost

    Measured: 2022-12-30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2020
  2. Study start16 Mar 2021
  3. Primary completion8 Nov 2023
  4. Study completion8 Nov 2023

Resources

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
Other
Time perspective
Prospective
Enrolment
3,520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536402
Sponsor's protocol ID
D5980R00016
Acronym
TORES
Status last verified
Jul 2024
First submitted
28 Aug 2020
Last updated
29 Jul 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 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

  • Sun Y, Chen Y, Zhang X, Guo R, Zhou L, Feng J, Xiong X, Xu W, Li G, Zhang J. A Real-World Prospective Observational Study to Describe the Safety Profile and Clinical Outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) In Chinese Patients with Chronic Obstructive Pulmonary Disease (COPD). COPD. 2026 Jul 20;23(1):2705830. doi: 10.1080/15412555.2026.2705830. Epub 2026 Jul 29.

    PubMed 42522405

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 40 sites in China.

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 5 inclusion and 4 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. 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?

Incidence of all AEs /SAEs (time frame: 2022-12-30). 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 NCT04536402, 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 29 Jul 2024.

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