- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675463
The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD (OCT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shiyue Li, Doctor
- Phone Number: +86 13902233925
- Email: lishiyue@188.com
Study Contact Backup
- Name: Ziqing Zhou, Doctor
- Phone Number: +86 13535580261
- Email: zhou.ziqing@foxmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Guangzhou Institute of Respiratory Diseases
-
Contact:
- Shiyue Li, Professor
- Phone Number: 13902233925
-
Contact:
- Ziqing Zhou, Doctor
- Phone Number: 13535580261
- Email: zhou.ziqing@foxmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Budesonide/Glycopyrronium/Formoterol arm
52 weeks treatment
|
Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/
puff, twice daily with two puffs per time
Other Names:
|
Other: Glycopyrronium/Formoterol arm
52 weeks treatment
|
Glycopyrronium/Formoterol: 7.2/4.8
per puff, twice daily with two puffs per time
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effect of BGF and GFF on luminal diameter change
Time Frame: 12 months
|
•Change from baseline in mean luminal diameter of the 7th to 9th generation bronchi (Dmean7-9) at month 12 measured by EB-OCT
|
12 months
|
The effect of BGF and GFF on airway wall area change
Time Frame: 12 months
|
•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
|
12 months
|
The effect of BGF and GFF on resonant frequency
Time Frame: 12 months
|
•Change from baseline in resonant frequency (Fres) at month 6 and 12 measured by impulse oscillometry (IOS)
|
12 months
|
The effect of BGF and GFF on peripheral airway resistance
Time Frame: 12 months
|
•Change from baseline in peripheral airway resistance (R5-R20) at month 6 and 12 measured by IOS
|
12 months
|
The effect of BGF and GFF on lung function including FEV1, FVC,FEV1%
Time Frame: 12 months
|
•Change from baseline in trough FEV1, FVC and FEV1% at month 6 and 12 measured by spirometry
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory Objective: change of Quality of life
Time Frame: 12 months
|
• the effects of BGF and GFF in improving quality of life measured by St. George's Respiratory Questionnaire (SGRQ),Scores range from 0 to 100, with higher scores indicating more limitations.
|
12 months
|
Exploratory Objective: change of emphysema
Time Frame: 12 months
|
•the effects of BGF and GFF in reducing emphysema measured by Computer Tomography(CT)
|
12 months
|
Exploratory Objective: TNF-α
Time Frame: 12 months
|
• the effects of BGF and GFF in ameliorating COPD inflammation measured by TNF-α in sputum
|
12 months
|
Exploratory Objective: IL-1β
Time Frame: 12 months
|
• the effects of BGF and GFF in ameliorating COPD inflammation measured by IL-1β in sputum
|
12 months
|
Exploratory Objective: MMP-8
Time Frame: 12 months
|
• the effects of BGF and GFF in ameliorating COPD inflammation measured by MMP-8 in sputum
|
12 months
|
Exploratory Objective: MMP-12
Time Frame: 12 months
|
• the effects of BGF and GFF in ameliorating COPD inflammation measured by MMP-12 in sputum
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shiyue Li, Doctor, Guangzhou Institute of Respiratory Disease
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCT-19-20271
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Disease, Chronic Obstructive
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on BGF Inhalation Aerosphere
-
Jianxing HeNot yet recruitingCough | Drug Effect | Lung Cancer, Nonsmall Cell | Perioperative | Drug Toxicity
-
AstraZenecaCompletedChronic Obstructive Pulmonary Disease (COPD)United States, Canada, Germany, Argentina, Bulgaria, Poland, Turkey, Mexico, United Kingdom
-
Pearl Therapeutics, Inc.Completed
-
AstraZenecaParexelCompletedChronic Obstructive Pulmonary Disease (COPD)United States
-
AstraZenecaParexelNot yet recruiting
-
AstraZenecaNot yet recruitingChronic Obstructive Pulmonary DiseaseGermany, United Kingdom
-
Pearl Therapeutics, Inc.Completed
-
Pearl Therapeutics, Inc.CompletedCOPDUnited States, Austria, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, Peru, Russian Federation, Hungary, China, Taiwan, Australia, Japan, Argentina, South Africa, Belgium, Czechia, Serbia, Poland, Mexico, New... and more
-
AstraZenecaRecruitingAsthmaUnited States, China, Czechia, Germany, South Africa, United Kingdom, Mexico, Turkey, Colombia, Russian Federation, Brazil, Israel, Greece, Portugal, Austria, Costa Rica, Saudi Arabia, Slovakia, Sweden, Puerto Rico
-
Pearl Therapeutics, Inc.Completed