Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| The First Hospital of Hebei Medical University | OTHER |
| Fudan University | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxyhydrogen | Experimental | conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaled |
|
| oxygen | Experimental | conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxyhydrogen | Device | Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | everyday from the baseline to the seventh day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12564612 | Background | 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. | |
| 14665499 | Background | 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. |
Not provided
Not provided
the main evaluation index and the secondary evaluation index of all participants will be share in 3 months after the end of this study.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Shanghai Zhongshan Hospital |
| OTHER |
| Shanghai 10th People's Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
| Tianjin Medical University General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| Oxygen | Device | oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days |
|
| Conventional treatment | Drug | Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in seven days before the study |
|
| baseline and the seventh day |
| FEV1 | Change from Baseline in First second forcibly expiration quantity(FEV1) at 7 days | baseline and the seventh day |
| FVC | Change from Baseline in Forcibly vital capacity(FVC) at 7 days | 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 | baseline and the seventh day |
| PaO2 | Change from Baseline in Arterial oxygen tension (PaO2) at 7 days | baseline and the seventh day |
| PaCO2 | Change from Baseline in carbon dioxide arterial tension (PaCO2) at 7 days | baseline and the seventh day |
| Potential of Hydrogen | Change from Baseline in Potential of Hydrogen( Ph ) at 7 days | baseline and the seventh day |
| oxygen saturation of blood | Change from Baseline in oxygen saturation of blood at 7 days | 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. | everyday from the baseline to the seventh day |
| 33985501 | Derived | 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. |