Hydrogen/oxygen gas therapy for the treatment of COPDScientific Research
A Therapy for Improving Symptoms in Patients With Acute Exacerbations of COPD by Hydrogen-Oxygen Generator With Neburlizer.
https://www.clinicaltrials.gov/ct2/show/study/NCT04000451?term=04000451&draw=2&rank=1
Study description
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Copd Exacerbation Acute | Device: oxyhydrogenDevice: OxygenDrug: Conventional treatment | Not 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
| 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 |
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 baselineto 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
standard
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.
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 |
| Copd Exacerbation Acute oxygen oxyhydrogen |
| Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |
Published on: 26/03/2020
A Therapy for Improving Symptoms in Patients With Acute Exacerbations of COPD by Hydrogen-Oxygen Generator With Neburlizer.
https://www.clinicaltrials.gov/ct2/show/study/NCT04000451?term=04000451&draw=2&rank=1
Collaborators:The First Affiliated Hospital of Guangzhou Medical UniversityThe First Hospital of Hebei Medical UniversityThe Fifth People’s Hospital of Shanghai, Fudan UniversityShanghai Zhongshan HospitalShanghai 10th People’s HospitalThe First Affiliated Hospital of Zhengzhou UniversitySecond Hospital of Shanxi Medical UniversityShanghai Pulmonary Hospital, Shanghai, ChinaTianjin Medical University General HospitalInformation 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 Acute Device: oxyhydrogenDevice: OxygenDrug: Conventional treatment Not 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. ClinicArms and InterventionsGo to
Arm Intervention/treatment Experimental: oxyhydrogen conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaledDevice: oxyhydrogen Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven daysDrug: 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 studyExperimental: oxygen conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaledDevice: Oxygen oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven daysDrug: 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 studyMore InformationOutcome 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 baselineto day seven.
FEV1 Baseline and Day Seven
Change from Baseline in First Second Forced Expiration Amount (FEV1) after 7 daysFVC Baseline and Day Seven
Change from baseline in forced vital capacity (FVC) at 7 daysFEV1/FVC Baseline and Day 7
Change from baseline in forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) at 7 daysPaO2 baseline and day seven
Change from baseline in arterial partial pressure of oxygen (PaO2) after 7 daysPaCO2 Baseline and Day 7
Change from baseline in arterial carbon dioxide pressure (PaCO2) at 7 daysHydrogen Baseline and Seventh Day Potential
Change in hydrogen potential (Ph) from baseline after 7 daysDaily oxygen saturation from baseline to day seven
Change in oxygen saturation after 7 days from baselineDevice 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 MedicineChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: 40 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No standard
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.Go toPublications: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
oxygen
oxyhydrogenAdditional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
