The purpose for the trial is intended to evaluate safety and effectiveness of an oxyhydrogen generator with nebulizer in an adjuvant therapy for patients with severe asthma.
The oxyhydrogen generator with nebulizer in (treatment group) or control group was applied randomly for the patients with severe asthma in this study, then the therapeutic effects from both treatment and control groups were analyzed and evaluated to verify its safety and effectiveness.This study is a multi-center, randomized, double-blind study. Each patient was expected to participate in the trial for 104±3 day.The screening period was 14±1 days, and the subjects would continue to be applied with the previous asthma treatment scheme. The primary objective was to collect the baseline data related to the subjects.The patients would receive 30±1 day of treatment with the product; after that, observation of 60±1 days was required.Total patients number is 150 cases, of which 75 cases are treatment group and the others are control group.All cases respectively are distributed in 5 clinical hospitals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
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.
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGdifferentials from Mini Asthma Quality of life questionnaire (Mini AQLQ)
Mini Asthma Quality of life questionnaire (Mini AQLQ) was used for evaluation on asthma treatment after the subjects were treated, to determine the product effectiveness.
Time frame: at 3 months
differentials from asthma control questionnaire
the asthma control questionnaire (ACQ) was used for the evaluation on the subjects' asthma state after treatment, to determine effectiveness of the product.
Time frame: at 3 months
differentials from asthma control test (ACT)
The asthma control test (ACT) is used for evaluation of the asthma state after treatment, to determine effectiveness of the product.
Time frame: at 3 months
differentials from Peak Expiratory Flow (PEF) daily aberration rate
Peak Expiratory Flow (PEF) refers to the instant flow rate in the fastest expiratory flow in the forced vital capacity measurement process, mainly reflecting the strength of respiratory flow and airway obstruction.
Time frame: at 3 months
differentials from airway resistance measurement
The patient airway resistance was measured was measured, including: Rat5Hz, Rat20Hz, Xat5Hz, MeanR5\~R20 and AX.
Time frame: at 3 months
differentials from number of asthma acute attacks
The number of asthma acute attacks refers to the total number of the patient's asthma acute attacks in the observation period after the completion of hydrogen treatment.
Time frame: at 3 months
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differentials from number of uses of first-aid drugs
Number of uses of first aid drugs (short-term beta receptor stimulant) refers to the total number of administering salbutamol for relieving symptoms in the efficacy observation period after each subject completed hydrogen treatment.
Time frame: at 3 months
differentials from Special allergens
egg white, milk, fish, wheat, peanut, soybean (fx5); house dust, household dust mites, dust mites, cockroaches (hx2); Penicillium notatum/branch neurospora/Aspergillus fumigatus/Candida yeast/Alternaria neurospora/creep cinerea (mx2); inhaled allergen screening (Phadiatop); total IgE1.
Time frame: at 3 months
differentials from blood routine examination
Time frame: at 3 months
differentials from serum C reactive protein (CRP)
Time frame: at 3 months
differentials from liver function examination
Time frame: at 3 months
differentials from renal function examination
Time frame: at 3 months
differentials from electrolyte test
Time frame: at 3 months
differentials from routine urine test
Time frame: at 3 months
differentials from 12-lead ECG test
Time frame: at 3 months
differentials from urine pregnancy test for fertile women
Time frame: at 3 months
differentials from pulmonary function
Inspection items for patient pulmonary function include: FEV1.0, FEV1.0%, FVC, MMEF, MEF25, MEF50, MEF75, DLCO / VA, PEF †, FeNO, RV, TLC, RV / TLC, and FRC.
Time frame: at 3 months
differentials from Baseline in Serum interleukin-6(IL-6)
Time frame: at 3 months
differentials from Baseline in Serum interleukin-8( IL - 8)
Time frame: at 3 months
differentials from Baseline in Serum tumor necrosis factor-a(TNF-a)
Time frame: at 3 months
differentials from Baseline in Serum interleukin-4( IL - 4)
Time frame: at 3 months
differentials from Baseline in Serum interleukin-5( IL - 5)
Time frame: at 3 months
differentials from Baseline in Serum interleukin-13( IL - 13)
Time frame: at 3 months
differentials from Baseline in Serum interleukin-17( IL - 17)
Time frame: at 3 months
differentials from induced sputum test
proportions of eosinophils, macrophages, lymphocytes, and neutrophils;
Time frame: at 3 months