The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD

NCT04675463 | Unknown

• 1 other identifier: OCT-19-20271
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (5)

• The effect of BGF and GFF on luminal diameter change

  12 months

• The effect of BGF and GFF on airway wall area change

  12 months

• The effect of BGF and GFF on resonant frequency

  12 months

• The effect of BGF and GFF on peripheral airway resistance

  12 months

• The effect of BGF and GFF on lung function including FEV1, FVC,FEV1%

  12 months

Other Outcomes (6)

• Exploratory Objective: change of Quality of life

  12 months

• Exploratory Objective: change of emphysema

  12 months

• Exploratory Objective: TNF-α

  12 months

Study Arms (2)

Budesonide/Glycopyrronium/Formoterol arm

OTHER

52 weeks treatment

Drug: BGF Inhalation Aerosphere

Glycopyrronium/Formoterol arm

OTHER

52 weeks treatment

Drug: GFF Inhalation Aerosphere

Interventions

BGF Inhalation Aerosphere DRUG

Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time

Also known as: Breztri

Budesonide/Glycopyrronium/Formoterol arm

GFF Inhalation Aerosphere DRUG

Glycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time

Also known as: Bevespi

Glycopyrronium/Formoterol arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShiYue Li: lead
• AstraZeneca: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Diseases

Guangzhou, Guangdong, 510000, China

Location

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 Officials

• Shiyue Li, Doctor

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyue Li, Doctor

CONTACT

+86 13902233925; lishiyue@188.com

Ziqing Zhou, Doctor

CONTACT

+86 13535580261; zhou.ziqing@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 19, 2020
• Study Start: December 30, 2020
• Primary Completion: January 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

CN (1)