Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer

Study Overview
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Brief Summary
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The purpose for this study is to determine safety and effectiveness of the oxyhydrogen generator with nebulizer through an adjuvant therapy for the severe COPD patients in the stable phase.

Detailed Description
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In this study, severe COPD patients in stable phase who were included in both treatment and control groups, administered randomly oxyhydrogen generator with nebulizer (treatment group) or oxygen Nebulizer Machine （control group ）for adjuvant 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 3 months. The curative effect was observed for subjects in the second week, first month, second month and third month respectively as the observing time point. Total patients which are planned to be included are 140 cases, where, 70 cases in the treatment group and control group respectively are distributed in 5 clinical hospitals.

Official Title
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Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer: A Multi-centric, Randomized, Parallel-control and Double-blinded Clinic Study

Conditions
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COPD

Intervention / Treatment
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* Device: oxyhydrogen
* Device: Oxygen
* Drug: Conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: It conforms to the diagnostic criteria of chronic obstructive pulmonary diseases (COPD): (PFT)The percentage of forced expiratory volume in forced vital capacity in one second after inhaling vasodilator (FEV1 / FVC% < 70%); Classification of COPD severity by pulmonary function: The criterion for this study is Severe: FEV1/FVC<0.70, and FEV1< 50% expected value after pulmonary function was examined by taking bronchodilator. More than 40 years old and have normal ability to judge independently; men and women are not limited; Living in the vicinity of the test centre in the past six months; - Exclusion Criteria: 1) Those who have acute exacerbation in the past 4 weeks; 2) Lung disease history: Excluding the history of other lung diseases except combined COPD, such as combined pulmonary tuberculosis and diffuse pan-capillary bronchiolitis, pneumonia, pneumothorax, pleural effusion, pulmonary embolism, etc. 3) Those who suffer infectious diseases such as hepatitis A, hepatitis B, AIDS and tuberculosis or connective tissue diseases in the active period; 4) Those who suffer high fever, as well as various local or systemic infections (including respiratory, urinary and reproductive system, digestive system, sepsis, etc.), severe infection, especially lung infection found by CT examination; 5) Those who have limited ability to understand and poor compliance; do not have the legal capacity or limited legal capacity; participated in other clinical trials in the first 3 months when they were included in the groups; mental or physical disability; 6) Those who were difficult to make an exact evaluation on safety and effectiveness of products; 7) The women in pregnancy and lactation, as well as the women at childbearing age who don't agree to take effective contraceptive measures during the study period; 8) Those who have abnormal heart function and thrombophlebitis; 9) Those who are known and can't stand the oxygen and hydrogen inhalation; 10) Those who are suffered from primary diseases in important visceral organs and systems, such as stroke, severe hypertension, gastric ulcer, uncontrolled diabetes, malignant tumor, liver and kidney failure, and severe heart disease history (acute myocardial infarction, congestive heart failure and other heart diseases in the acute phase); 11) Cancer in progressive stage as well as undetermined masses found in the treatment; 12) Those who have one or more lobectomy history; 13) Those who are suspected to have or really have alcohol and drug abuse history; 14) Those whose AST and ALT≥120U/L, Ccr≤50ml/min; who have shock or unstable hemodynamics; 15) Those who are considered not to participate in clinical trials by the investigators.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxyhydrogen<br>conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaled | Device: oxyhydrogen<br>* Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.<br>* Other names: Oxyhydrogen generator with nebulizer;Drug: Conventional treatment<br>* Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months before the study.<br>* Other names: medication treatment;|
| Experimental: oxygen<br>conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled | Device: Oxygen<br>* oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.<br>* Other names: Medical molecular sieve oxygenerator;Drug: Conventional treatment<br>* Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months before the study.<br>* Other names: medication treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in dyspnea index score (mMRC score) at 3 months |  | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in St George's respiratory questionnaire (SGRQ score) at 3 months |  | baseline and 3 months | 
| Change from Baseline in Six minute walk distance at 3 months |  | baseline and 3 months | 
| Change from Baseline in Pulmonary artery pressure measured by heart color Doppler ultrasound at 3 months |  | baseline and 3 months | 
| Change from Baseline in Forcibly vital capacity(FVC) at 3 months |  | baseline and 3 months | 
| Change from Baseline in First second forcibly expiration quantity(FEV1) at 3 months |  | baseline and 3 months | 
| Change from Baseline in mean maximum expiratory flow(MMEF) at 3 months |  | baseline and 3 months | 
| Change from Baseline in Residual volume(RV) at 3 months |  | baseline and 3 months | 
| Change from Baseline in Serum interleukin-6(IL-6) at 3 months |  | baseline and 3 months | 
| Change from Baseline in Serum interleukin-8( IL - 8) at 3 months |  | baseline and 3 months | 
| Change from Baseline in Serum tumor necrosis factor-a(TNF-a) at 3 months |  | baseline and 3 months | 
| Change from Baseline in Serum malondialdehyde (MDA) at 3 months |  | baseline and 3 months | 
| Change from Baseline in Serum 8-isoprostane at 3 months |  | baseline and 3 months | 
| Change from Baseline in Arterial oxygen tension (PaO2) at 3 months |  | baseline and 3 months | 
| Change from Baseline in carbon dioxide arterial tension (PaCO2) at 3 months |  | baseline and 3 months | 
| number of participants with adverse events | the adverse events including chest distress,wheezing,cough,heartbeat accelerating,abdominal pain,diarrhea,nausea,vomiting,cardiac,liver, renal toxicity , etc. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, hydrogen