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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in seven days before the study
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Breathlessness, Cough, and Sputum Scale(BCSS score)
The breathlessness, cough and sputum scale (BCSS) is a three-item questionnaire rating breathlessness, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms).the total total is 12. Variables to be measured or calculated are: from the Baseline to the seventh day.
Time frame: everyday from the baseline to the seventh day
COPD assessment test (CAT)
CAT includes eight items describing the presence or absence of cough, mucus production, chest tightness,ff ort dyspnoea, limitation of activities at home, sense of confidence about leaving the home, sleep and the feeling of having lots of energy. Th e symptoms are assessed on a six-point scale from 0 to 5. Th e main outcome measure is the total score, where 0 indicates the absence of any negative infl uence of disease and 40 the worst imagin-able health status , Variables to be measured or calculated are: from the Baseline to the seventh day.
Time frame: baseline and the seventh day
FEV1
Change from Baseline in First second forcibly expiration quantity(FEV1) at 7 days
Time frame: baseline and the seventh day
FVC
Change from Baseline in Forcibly vital capacity(FVC) at 7 days
Time frame: baseline and the seventh day
FEV1/FVC
Change from Baseline in Forced Expiratory Volume in the first second/Forcibly vital capacity(FEV1/FVC) at 7 days
Time frame: baseline and the seventh day
PaO2
Change from Baseline in Arterial oxygen tension (PaO2) at 7 days
Time frame: baseline and the seventh day
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PaCO2
Change from Baseline in carbon dioxide arterial tension (PaCO2) at 7 days
Time frame: baseline and the seventh day
Potential of Hydrogen
Change from Baseline in Potential of Hydrogen( Ph ) at 7 days
Time frame: baseline and the seventh day
oxygen saturation of blood
Change from Baseline in oxygen saturation of blood at 7 days
Time frame: everyday from the baseline to the seventh day
Results Of Performance Evaluation Of Apparatus
During the treatment period of each subject, the performance of the test instrument must be evaluated from the following 3 aspects every day after treatment, and the percentage of "good" should be calculated. Good: The clinical use of the product is more convenient, easy to operate, no fault; General: Normal clinical use of the product, General Operation Requirements, there are occasional small failures. Poor: The product is difficult to use, more difficult operation, there are more failures. Variables to be measured or calculated are:Results of instrument performance evaluation at the end of each treatment day.
Time frame: everyday from the baseline to the seventh day