Pulmonary Disease, Chronic ObstructiveOCTNCT04675463
The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD
A study testing BGF Inhalation Aerosphere and GFF Inhalation Aerosphere in people with Pulmonary Disease, Chronic Obstructive, run by ShiYue Li at 1 site in China.
Trial summary
The fixed-dose combination product Budesonide/Glycopyrronium/Formoterol Fumarate Inhalation Aerosol, BGF pMDI and dual combination product Glycopyrronium/Formoterol Fumarate Inhalation Aerosol , GFF pMDI are developed for maintenance treatment for patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- BGF Inhalation Aerosphere and GFF Inhalation Aerosphere
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2020to 30 Jun 2023
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With capability of communicating via oral conversation or written documents and signing informed consent.
- With capability of receiving and participating in study related auxiliary examinations.
- Age: 40-80 yrs, both male and female, with or without smoking history, receiving treatment in community hospitals or outpatient department in general hospitals
- GOLD Stage II-III COPD: FEV1/FVC<70% and FEV1 45-80% predicted (about 1/3 subjects in 45%-50%), measured 20min after 400μg salbutamol inhalation
- With stable COPD (no COPD exacerbation during the latest 4 weeks prior to the recruitment) and irregular use of inhalation therapy, or regular use of inhalation therapy but no more than 2 weeks. Subject is willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol.
Who cannot join
- Subjects are participating in other clinical research or have completed another clinical research within 3 months prior to screening.
- Significant diseases or conditions other than COPD. A significant disease or condition is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study
- Patients with clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, or other single restricted ventilation.
- Severe cardiovascular, neural, hepatic, renal and hematologic diseases or malignancies that may interfere with the operation of the study.
- Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms, or narrow angle glaucoma
- Patients have a current and history diagnosis of asthma, or who have a blood eosinophil count ≥600/mm3 (0.6×109/L).
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- Patients with active pulmonary tuberculosis
- Patients with life-threatening pulmonary embolism, α1-antitrypsin deficiency, or cystic fibrosis
- History of pneumonectomy.
- COPD exacerbation in 4 weeks prior to the first visit (V1), or hospitalization and/or antibiotic application and/or oral or intravenous glucocorticosteroids application is required during screening stage.
- Long-term oxygen therapy, frequent use of glucocorticosteroids orally or intravenously (prednisone>10mg/d), or long-term use of antibiotics.
- Women who are pregnant or lactating or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- Planned hospitalization or blood donation during the trial.
- Known hypersensitivity or intolerance to trial drugs.
- History of chronic alcohol or drug abuse, or any other conditions that may impact compliance.
- With contraindications to undergo bronchoscopy.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, 510000
Shiyue Li, Professor, 13902233925
Ziqing Zhou, Doctor, 13535580261, zhou.ziqing@foxmail.com
About this study
Official title: An Open Label, Single-center, Prospective, Interventional Pilot Study to Evaluate the Effects of Inhaled Budesonide-formoterol-glycopyrronium and Formoterol-glycopyrronium in Moderate-to-severe Chronic Obstructive Pulmonary Disease
The fixed-dose combination product Budesonide/Glycopyrronium/Formoterol Fumarate Inhalation Aerosol, BGF pMDI and dual combination product Glycopyrronium/Formoterol Fumarate Inhalation Aerosol , GFF pMDI are developed for maintenance treatment for patients with COPD.
There are still some unmet medical needs and evidence gaps in COPD therapy, such as could BGF Inhalation Aerosphere reverse the disease progression such like airway-remodelling? Could BGF Inhalation Aerosphere reduce inflammation in small airways? Before differences proven between medication groups, pilot study is needed.
This 52 weeks, Single-center, prospective, interventional pilot study could help discovering intervention effect of BGF and GFF on small airways through OCT measurement, which would show outcome of AEROSPHERE™ Delivery Technology on COPD patients.
Read the detailed description
The subjects eligible for this study will receive a 52-week of BGF or GFF treatment, and a 30 days follow-up telephone call after the last study drug dose.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BGF Inhalation Aerosphere, GFF Inhalation Aerosphere
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGF Inhalation AerosphereDrug
Also called Breztri
Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time
GFF Inhalation AerosphereDrug
Also called Bevespi
Glycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time
| Study group | Role | What they receive |
|---|---|---|
| Budesonide/Glycopyrronium/Formoterol arm | Other | 52 weeks treatment Receives: Drug: BGF Inhalation Aerosphere |
| Glycopyrronium/Formoterol arm | Other | 52 weeks treatment Receives: Drug: GFF Inhalation Aerosphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of BGF and GFF on inner luminal area change
Change from baseline in the inner luminal area of the 7th to 9th generation bronchi (Ai7-9) at month 12 measured by Endobronchial optical coherence tomography (EB-OCT)
Measured: 12 months
Secondary outcomes (5)
The effect of BGF and GFF on luminal diameter change
•Change from baseline in mean luminal diameter of the 7th to 9th generation bronchi (Dmean7-9) at month 12 measured by EB-OCT
Measured: 12 months
The effect of BGF and GFF on airway wall area change
•Change from baseline in airway wall area percentage of the 7th to 9th generation bronchi (Aw%7-9) at month 12 measured by EB-OCT
Measured: 12 months
The effect of BGF and GFF on resonant frequency
•Change from baseline in resonant frequency (Fres) at month 6 and 12 measured by impulse oscillometry (IOS)
Measured: 12 months
The effect of BGF and GFF on peripheral airway resistance
•Change from baseline in peripheral airway resistance (R5-R20) at month 6 and 12 measured by IOS
Measured: 12 months
The effect of BGF and GFF on lung function including FEV1, FVC,FEV1%
•Change from baseline in trough FEV1, FVC and FEV1% at month 6 and 12 measured by spirometry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start30 Dec 2020 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShiYue Li
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, Doctor, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675463
- Sponsor's protocol ID
- OCT-19-20271
- Acronym
- OCT
- Status last verified
- Dec 2020
- First submitted
- 27 Nov 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-center, Prospective, Interventional Pilot Study to Evaluate the Effects of Inhaled Budesonide-formoterol-glycopyrronium and Formoterol-glycopyrronium in Moderate-to-severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04675463
- Acronym / sponsor ID
- OCT / OCT-19-20271
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ShiYue LiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 30 Dec 2020 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 19 Dec 2020 (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.
The fixed-dose combination product Budesonide/Glycopyrronium/Formoterol Fumarate Inhalation Aerosol, BGF pMDI and dual combination product Glycopyrronium/Formoterol Fumarate Inhalation Aerosol , GFF pMDI are developed for maintenance treatment for patients with COPD.
There are still some unmet medical needs and evidence gaps in COPD therapy, such as could BGF Inhalation Aerosphere reverse the disease progression such like airway-remodelling? Could BGF Inhalation Aerosphere reduce inflammation in small airways? Before differences proven between medication groups, pilot study is needed.
This 52 weeks, Single-center, prospective, interventional pilot study could help discovering intervention effect of BGF and GFF on small airways through OCT measurement, which would show outcome of AEROSPHERE™ Delivery Technology on COPD patients.
Detailed description
The subjects eligible for this study will receive a 52-week of BGF or GFF treatment, and a 30 days follow-up telephone call after the last study drug dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide/Glycopyrronium/Formoterol arm | Other | Drug: BGF Inhalation Aerosphere52 weeks treatment |
| Glycopyrronium/Formoterol arm | Other | Drug: GFF Inhalation Aerosphere52 weeks treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With capability of communicating via oral conversation or written documents and signing informed consent.
- With capability of receiving and participating in study related auxiliary examinations.
- Age: 40-80 yrs, both male and female, with or without smoking history, receiving treatment in community hospitals or outpatient department in general hospitals
- GOLD Stage II-III COPD: FEV1/FVC<70% and FEV1 45-80% predicted (about 1/3 subjects in 45%-50%), measured 20min after 400μg salbutamol inhalation
- With stable COPD (no COPD exacerbation during the latest 4 weeks prior to the recruitment) and irregular use of inhalation therapy, or regular use of inhalation therapy but no more than 2 weeks. Subject is willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol.
Key exclusion criteria (16 listed)
- Subjects are participating in other clinical research or have completed another clinical research within 3 months prior to screening.
- Significant diseases or conditions other than COPD. A significant disease or condition is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study
- Patients with clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, or other single restricted ventilation.
- Severe cardiovascular, neural, hepatic, renal and hematologic diseases or malignancies that may interfere with the operation of the study.
- Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms, or narrow angle glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGF Inhalation AerosphereAlso: BreztriBudesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time | Drug | Budesonide/Glycopyrronium/Formoterol arm |
| GFF Inhalation AerosphereAlso: BevespiGlycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time | Drug | Glycopyrronium/Formoterol arm |
Primary outcome
The effect of BGF and GFF on inner luminal area change
Time frame: 12 months
Change from baseline in the inner luminal area of the 7th to 9th generation bronchi (Ai7-9) at month 12 measured by Endobronchial optical coherence tomography (EB-OCT)
5 secondary outcomes
The effect of BGF and GFF on luminal diameter change
Time frame: 12 months
The effect of BGF and GFF on airway wall area change
Time frame: 12 months
The effect of BGF and GFF on resonant frequency
Time frame: 12 months
The effect of BGF and GFF on peripheral airway resistance
Time frame: 12 months
The effect of BGF and GFF on lung function including FEV1, FVC,FEV1%
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
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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.
Shiyue Li, Doctor principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BGF Inhalation Aerosphere and GFF Inhalation Aerosphere in people with Pulmonary Disease, Chronic Obstructive, run by ShiYue Li at 1 site 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 16 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: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li, Doctor (+86 13902233925, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of BGF and GFF on inner luminal area change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2020.