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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
170
Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months before the study.
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGChange from Baseline in dyspnea index score (mMRC score) at 3 months
Time frame: baseline and 3 months
Change from Baseline in St George's respiratory questionnaire (SGRQ score) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Six minute walk distance at 3 months
Time frame: baseline and 3 months
Change from Baseline in Pulmonary artery pressure measured by heart color Doppler ultrasound at 3 months
Time frame: baseline and 3 months
Change from Baseline in Forcibly vital capacity(FVC) at 3 months
Time frame: baseline and 3 months
Change from Baseline in First second forcibly expiration quantity(FEV1) at 3 months
Time frame: baseline and 3 months
Change from Baseline in mean maximum expiratory flow(MMEF) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Residual volume(RV) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum interleukin-6(IL-6) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum interleukin-8( IL - 8) at 3 months
Time frame: baseline and 3 months
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Change from Baseline in Serum tumor necrosis factor-a(TNF-a) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum malondialdehyde (MDA) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum 8-isoprostane at 3 months
Time frame: baseline and 3 months
Change from Baseline in Arterial oxygen tension (PaO2) at 3 months
Time frame: baseline and 3 months
Change from Baseline in carbon dioxide arterial tension (PaCO2) at 3 months
Time frame: 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.
Time frame: up to 3 months