NCT04000451

A Therapy for Improving Symptoms in Patients With Acute Exacerbations of COPD by Hydrogen-Oxygen Generator With Neburlizer.

A Therapy for Improving Symptoms in Patients With Acute Exacerbations of Copd by an Hydrogen-Oxygen Generator With Neburlizer: A Multi-centric, Randomized, Parallel-control and Double-blinded Clinic Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Shanghai Asclepius Meditec Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose for this study is to determine safety and effectiveness of the oxyhydrogen generator with nebulizer through a therapy for improving symptoms in patients with acute exacerbations of copd.

Detailed description

In this study, patients with acute exacerbations of copd who were included in both treatment and control groups, administered randomly oxyhydrogen generator with nebulizer (treatment group) or oxygen Nebulizer Machine (control group for the therapy. The therapeutic outcomes in both treatment and control groups are analyzed and evaluated to verify safety and effectiveness of the test product. This study is a multi-center, randomized, double-blind study. The trial lasted for about 10 days. The curative effect was observed for subjects in the First, the second, the third, the fourth, the fifth, the sixth, the seventh day, respectively as the observing time point. Total patients which are planned to be included are 108 cases, where, 54 cases in the treatment group and control group respectively are distributed in 10 clinical hospitals

Conditions

• Copd Exacerbation Acute

Interventions

Type	Name	Description
DEVICE	oxyhydrogen	Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
DEVICE	Oxygen	oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
DRUG	Conventional treatment	Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in seven days before the study

Timeline

• Start date: 2019-01-07
• Primary completion: 2019-06-01
• Completion: 2019-09-20
• First posted: 2019-06-27
• Last updated: 2020-03-26

Locations

1 site across 1 country: China