Clinical trial NCT04000451: A Therapy for Improving Symptoms in Patients With Acute Exacerbations of COPD by Hydrogen-Oxygen Generator With Neburlizer.
Official title: A Therapy for Improving Symptoms in Patients With Acute Exacerbations of Copd by an Hydrogen-Oxygen Generator With Neburlizer: A Multi-centric, Randomized, Parallel-control and Double-blinded Clinic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd Exacerbation Acute
Keywords: Copd Exacerbation Acute
oxygen
oxyhydrogen
Lead sponsor: Shanghai Asclepius Meditec Inc.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
name: The First Hospital of Hebei Medical University
name: Fudan University
name: Shanghai Zhongshan Hospital
name: Shanghai 10th People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Second Hospital of Shanxi Medical University
name: Shanghai Pulmonary Hospital, Shanghai, China
name: Tianjin Medical University General Hospital
First posted: 2019-06-27
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. meet the diagnostic criteria of chronic obstructive pulmonary disease (COPD)\[1\] : In the examination of pulmonary function, after inhalation of bronchodilator, the volume of forced air in one second accounted for 70% of forced vital capacity (FEV1 / FVC%) , fev180% ;
2. meet the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)\[2\] : compared with the stable phase, the patient's condition has continued to deteriorate, more than the normal changes in the daytime, that is, patients with chronic obstructive pulmonary disease foundation for acute onset, need to adjust the routine medication. There are at least 2 of the following 3 items in the continuous deterioration of clinical symptoms: 1 aggravation of shortness of breath; 2 increase of 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 increased respiratory frequency and heart rate by 20% compared with the baseline; 3 aggravated cough; 4 Pharyngodynia and runny in the last 5 days; 5 increased wheezing;
3. the age is over 40 years old and has the normal independent judgment ability patient, the male and the female are not limited;
4. AECOPD patients requiring in-patient Care;
5. patients with BCSS score ≥6 at the time of admission;
6. patients who volunteer for the trial and sign an informed consent form.

Exclusion Criteria:

1. screening period of intravenous or oral administration of more than 80 mg / day of methylprednisolone or equivalent dose of other hormones or serious need for continuous non-invasive ventilation patients;
2. having a significant disease other than COPD, which, according to the researchers'judgement, would put the participants at risk for participating in the study or have an impact on the results of the study and the participants'ability to participate in the study;
3. other respiratory diseases: subjects with other active pulmonary diseases, such as active tuberculosis, lung cancer, bronchiectasis disease (CT showed repeated acute exacerbations of bronchiectasis disease) , sarcoidosis, idiopathic interstitial pulmonary fibrosis (IPF) , primary pulmonary hypertension, uncontrolled Sleep apnea (i.e. , according to the researchers, the severity of the disease would influence the study) ;
4. Lung Rehabilitation: Participants in the Lung Rehabilitation Program during the study period;
5. a history of severe heart disease such as acute myocardial infarction, congestive heart failure (NYHA Class III and above) , Severe Arrhythmia and other acute heart disease;
6. serious primary diseases of important organs and systems, such as acute stroke, hypertension above moderate after treatment, active gastric ulcer, diabetes Mellitus (serious complication) , malignant tumor, etc.
7. confirmed and suspected cases of lung cancer;
8. a history of one or more lobectomies;
9. limited understanding and poor compliance;
10. lack of or restricted legal capacity;
11. those who have participated in clinical trials of other drugs or medical devices within 30 days prior to screening but have not reached the end point of the trial;
12. pregnant, lactating women and women of childbearing age who do not agree to effective contraceptive measures during the study period;
13. Persons with mental or physical disabilities;
14. a suspected or confirmed history of alcohol or Drug Abuse;
15. those who are known to be intolerant to inhalation therapy;
16. AST, ALT were 3 times higher than the normal upper limit, creatinine ≥176.8 MMOL / l;
17. shock or other Hemodynamics instability;
18. people with active Hepatitis A, hepatitis B, HIV, tuberculosis, and Infectious Disease Connective Tissue Disease;
19. intravenous hormone therapy for more than 5 days after an acute episode;
20. non expectorant antioxidants, including high doses of vitamin C and Vitamin E;
21. the researcher did not consider it appropriate to participate in this study.

Primary outcomes:
measure: The Breathlessness, Cough, and Sputum Scale(BCSS score)
timeFrame: everyday from the baseline to the seventh day
Secondary outcomes:
measure: COPD assessment test (CAT)
timeFrame: baseline and the seventh day
measure: FEV1
timeFrame: baseline and the seventh day
measure: FVC
timeFrame: baseline and the seventh day
measure: FEV1/FVC
timeFrame: baseline and the seventh day
measure: PaO2
timeFrame: baseline and the seventh day
measure: PaCO2
timeFrame: baseline and the seventh day
measure: Potential of Hydrogen
timeFrame: baseline and the seventh day
measure: oxygen saturation of blood
timeFrame: everyday from the baseline to the seventh day
measure: Results Of Performance Evaluation Of Apparatus
timeFrame: everyday from the baseline to the seventh day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
citation: Leidy NK, Schmier JK, Jones MK, Lloyd J, Rocchiccioli K. Evaluating symptoms in chronic obstructive pulmonary disease: validation of the Breathlessness, Cough and Sputum Scale. Respir Med. 2003 Jan;97 Suppl A:S59-70.
citation: Leidy NK, Rennard SI, Schmier J, Jones MK, Goldman M. The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretation. Chest. 2003 Dec;124(6):2182-91. doi: 10.1378/chest.124.6.2182.
citation: Zheng ZG, Sun WZ, Hu JY, Jie ZJ, Xu JF, Cao J, Song YL, Wang CH, Wang J, Zhao H, Guo ZL, Zhong NS. Hydrogen/oxygen therapy for the treatment of an acute exacerbation of chronic obstructive pulmonary disease: results of a multicenter, randomized, double-blind, parallel-group controlled trial. Respir Res. 2021 May 13;22(1):149. doi: 10.1186/s12931-021-01740-w.