Hydrogen/oxygen gas therapy for the treatment of COPDScientific Research



Published on: 26/03/2020

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


The First Affiliated Hospital of Guangzhou Medical University
The First Hospital of Hebei Medical University
The Fifth People’s Hospital of Shanghai, Fudan University
Shanghai Zhongshan Hospital
Shanghai 10th People’s Hospital
The First Affiliated Hospital of Zhengzhou University
Second Hospital of Shanxi Medical University
Shanghai Pulmonary Hospital, Shanghai, China
Tianjin Medical University General Hospital
Information provided by (Responsible Party):
Shanghai Asclepius Meditec Inc.

Study description

Brief 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.


Condition or disease Intervention/treatment Phase 
Copd Exacerbation AcuteDevice: oxyhydrogenDevice: OxygenDrug: Conventional treatmentNot Applicable

Detailed description:
In this study, both treatment and control groups included patients with exacerbations of COPD who were randomized to receive either a nebulized electrolytic gas generator (treatment group) or an oxygen nebulizer (treatment control group). Treatment outcomes in the treatment and control groups will be analyzed and evaluated to verify the safety and efficacy of the test product. This study is a multicenter, randomized, double-blind study. The study lasted about 10 days. The curative probands were observed on the 1st, 2nd, 3rd, 4th, 5th, 6th, and 7th days. A total of 108 cases were admitted to the hospital, including 54 cases in the treatment group and 10 cases in the control group. Clinic

Arms and Interventions
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Arm Intervention/treatment 
Experimental: oxyhydrogen

conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaled
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

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
Experimental: oxygen

conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled
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
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Outcome measures

Main outcome measures:
Daily Shortness of Breath, Cough and Sputum Scale (BCSS Score) from Baseline to Day Seven
The Shortness of Breath, Cough, and Sputum Scale (BCSS) is a three-item questionnaire that rates shortness of breath, cough, and sputum production on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms). The total is 12. Variables to be measured or calculated: from baseline to day 7.

Secondary outcome measures:
COPD Assessment Test (CAT) Baseline and Day Seven
The CAT includes eight items describing the presence or absence of cough, mucus production, chest tightness, shortness of breath, restricted activities at home, confidence to leave home, sleep, and energy. Symptoms are scored on a six-point scale from 0 to 5.

.The key outcome measure is an overall score, with 0 being the absence of any ill-health and 40 being the worst imaginable health. , the variable to be measured or calculated is: from baseline​​​to day seven.

FEV1 Baseline and Day Seven
Change from Baseline in First Second Forced Expiration Amount (FEV1) after 7 days

FVC Baseline and Day Seven
Change from baseline in forced vital capacity (FVC) at 7 days

FEV1/FVC Baseline and Day 7
Change from baseline in forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) at 7 days

PaO2 baseline and day seven
Change from baseline in arterial partial pressure of oxygen (PaO2) after 7 days

PaCO2 Baseline and Day 7
Change from baseline in arterial carbon dioxide pressure (PaCO2) at 7 days

Hydrogen Baseline and Seventh Day Potential
Change in hydrogen potential (Ph) from baseline after 7 days

Daily oxygen saturation from baseline to day seven
Change in oxygen saturation after 7 days from baseline

Device performance assessment results daily from baseline to day seven
During each subject’s treatment period, the performance of the test apparatus must be evaluated according to the following 3 aspects every day after treatment, and the percentage of “good” is calculated.

Good: The product is more convenient for clinical use, easy to use, and error-free; General: The product is used normally in clinical practice, the operation requirements are general, and there are occasional small errors.

Poor: The product is difficult to use, and the harder it is to use, the more failures. The variables to be measured or calculated are: Results of device performance assessments at the end of each treatment day.

Eligibility Criteria

Information from the National Library of Medicine 

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Ages Eligible for Study:40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:All
Accepts Healthy Volunteers:No

Inclusion criteria:

Meet the diagnostic criteria for chronic obstructive pulmonary disease (COPD) [1]: when checking lung function after inhalation of bronchodilators, forced ventilation within one second occupies 70% of forced vital capacity (FEV1/FVC%), fev180%;
Meets the diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) [2]: The patient’s condition continues to deteriorate beyond the normal changes during the day, ie, compared to the stable period. H. Patients with chronic obstructive pulmonary disease have an underlying acute onset, and routine medication needs to be adjusted. Persistent worsening of clinical symptoms with at least 2 of the following 3 points:1 Worsening shortness of breath; 2 Increased sputum volume; 3 Purulent sputum; or at least 1 of the above 3 symptoms, but one of the other 5 indicators should be added, 1 fever; 2 Compared with baseline, respiratory rate and heart rate increased by 20% ; 3 Worsening cough; 4 sore throats and walking in the last 5 days; 5 Increased wheezing;
Patients over 40 years old with normal independent judgment ability, male or female;
AECOPD patients requiring hospitalization;
Patients with BCSS score ≥6 on admission;
Patients who volunteered to participate in the study and signed informed consent.

Exclusion Criteria:

During the screening period, intravenous or oral methylprednisolone or equivalent doses of more than 80 mg / day of other hormones or severe need for continuous non-invasive ventilation;
Having a significant medical condition other than COPD determined by the investigator that puts the participant at risk of participating in the study or affects the study results and the participant’s ability to participate in the study;
Other Respiratory Diseases: People with other active lung disease, such as B. active tuberculosis, lung cancer, bronchiectasis (recurrent exacerbations of bronchiectasis on CT), sarcoidosis, idiopathic interstitial lung Fibrosis (IPF), primary pulmonary hypertension, uncontrolled sleep apnea (ie, according to the researchers, the disease affects the study);
Pulmonary rehabilitation:Participants in a pulmonary rehabilitation program during the study period;
A history of serious heart disease, such as acute myocardial infarction, congestive heart failure (NYHA class III and above), severe arrhythmia, and other acute heart disease;
Serious underlying diseases of vital organs and systems, such as acute stroke, high blood pressure after treatment, active gastric ulcer, diabetes (serious complications), malignant tumors, etc.
Confirmed and suspected cases of lung cancer;
History of one or more lobectomies;
Limited understanding and poor compliance;
lack of or limited legal capacity;

Those who have participated in clinical trials of other drugs or medical devices within 30 days before screening but have not yet reached the research end point;
Pregnant women, lactating women and women of childbearing age who did not agree to use effective contraception during the study period;
a person with a mental or physical disability;
Suspected or confirmed history of alcohol or drug abuse;
those with known intolerance to inhalation therapy;
AST and ALT were 3 times higher than the upper limit of normal, and creatinine was ≥176.8 MMOL/L;
shock or other hemodynamic instability;People with active hepatitis A, hepatitis B, HIV, tuberculosis and connective tissue disease;
Intravenous corticosteroid therapy for more than 5 days after an acute attack;
non-expectant antioxidants, including high doses of vitamin C and vitamin E;
The researchers did not consider it appropriate to participate in this study.

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:Shanghai Asclepius Meditec Inc.
ClinicalTrials.gov Identifier:NCT04000451     History of Changes
Other Study ID Numbers:HM20180607
First Posted:June 27, 2019    Key Record Dates
Last Update Posted:March 26, 2020
Last Verified:March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:Yes
Plan Description:the main evaluation index and the secondary evaluation index of all participants will be share in 3 months after the end of this study.
Supporting Materials:Study Protocol
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
Keywords provided by Shanghai Asclepius Meditec Inc.:
Copd Exacerbation Acute
Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases