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

NCT04675463 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-12-19

No results posted yet for this study

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

Interventions

DRUG

BGF Inhalation Aerosphere

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

DRUG

GFF Inhalation Aerosphere

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • ShiYue Li

    lead OTHER

Principal Investigators

  • Shiyue Li, Doctor · Guangzhou Institute of Respiratory Disease

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2023-01-30
Completion
2023-06-30

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04675463 on ClinicalTrials.gov