Copd Exacerbation AcuteNCT04000451
A Therapy for Improving Symptoms in Patients With Acute Exacerbations of COPD by Hydrogen-Oxygen Generator With Neburlizer.
A study testing oxyhydrogen, Oxygen and Conventional treatment in people with Copd Exacerbation Acute, run by Shanghai Asclepius Meditec Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd Exacerbation Acute
- What is being tested?
- oxyhydrogen, Oxygen and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2019to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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% ;
- 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;
- the age is over 40 years old and has the normal independent judgment ability patient, the male and the female are not limited;
- AECOPD patients requiring in-patient Care;
- patients with BCSS score ≥6 at the time of admission;
- patients who volunteer for the trial and sign an informed consent form.
Who cannot join
- 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;
- 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;
- 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) ;
- Lung Rehabilitation: Participants in the Lung Rehabilitation Program during the study period;
- 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;
- 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.
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- confirmed and suspected cases of lung cancer;
- a history of one or more lobectomies;
- limited understanding and poor compliance;
- lack of or restricted legal capacity;
- 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;
- pregnant, lactating women and women of childbearing age who do not agree to effective contraceptive measures during the study period;
- Persons with mental or physical disabilities;
- a suspected or confirmed history of alcohol or Drug Abuse;
- those who are known to be intolerant to inhalation therapy;
- AST, ALT were 3 times higher than the normal upper limit, creatinine ≥176.8 MMOL / l;
- shock or other Hemodynamics instability;
- people with active Hepatitis A, hepatitis B, HIV, tuberculosis, and Infectious Disease Connective Tissue Disease;
- intravenous hormone therapy for more than 5 days after an acute episode;
- non expectorant antioxidants, including high doses of vitamin C and Vitamin E;
- the researcher did not consider it appropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
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
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.
Read the 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
- Conditions
- Copd Exacerbation Acute
- Being tested
- oxyhydrogen, Oxygen, Conventional treatment
- Keywords
- Copd Exacerbation Acute, oxygen, oxyhydrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxyhydrogenDevice
Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
OxygenDevice
oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
Conventional treatmentDrug
Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in seven days before the study
| Study group | Role | What they receive |
|---|---|---|
| oxyhydrogen | Experimental | conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaled Receives: Device: oxyhydrogen; Drug: Conventional treatment |
| oxygen | Experimental | conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled Receives: Device: Oxygen; Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: everyday from the baseline to the seventh day
Secondary outcomes (9)
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.
Measured: baseline and the seventh day
FEV1
Change from Baseline in First second forcibly expiration quantity(FEV1) at 7 days
Measured: baseline and the seventh day
FVC
Change from Baseline in Forcibly vital capacity(FVC) at 7 days
Measured: 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
Measured: baseline and the seventh day
PaO2
Change from Baseline in Arterial oxygen tension (PaO2) at 7 days
Measured: baseline and the seventh day
PaCO2
Change from Baseline in carbon dioxide arterial tension (PaCO2) at 7 days
Measured: baseline and the seventh day
Potential of Hydrogen
Change from Baseline in Potential of Hydrogen( Ph ) at 7 days
Measured: baseline and the seventh day
oxygen saturation of blood
Change from Baseline in oxygen saturation of blood at 7 days
Measured: 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.
Measured: everyday from the baseline to the seventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start7 Jan 2019
- Primary completion1 Jun 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Copd Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Asclepius Meditec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, The First Hospital of Hebei Medical University, Fudan University, Shanghai Zhongshan Hospital, Shanghai 10th People's Hospital, The First Affiliated Hospital of Zhengzhou University, Second Hospital of Shanxi Medical University, Shanghai Pulmonary Hospital, Shanghai, China, Tianjin Medical University General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000451
- Sponsor's protocol ID
- HM20180607
- Status last verified
- Mar 2020
- First submitted
- 18 Jun 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the main evaluation index and the secondary evaluation index of all participants will be share in 3 months after the end of this study.
Publications
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.
PubMed 12564612Leidy 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.
PubMed 14665499Zheng 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.
PubMed 33985501
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04000451
- Acronym / sponsor ID
- HM20180607
- Conditions
- Copd Exacerbation Acute
- Keywords
- Copd Exacerbation Acute, oxygen, oxyhydrogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Shanghai Asclepius Meditec Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, The First Hospital of Hebei Medical University, Fudan University, Shanghai Zhongshan Hospital, Shanghai 10th People's Hospital, The First Affiliated Hospital of Zhengzhou University, Second Hospital of Shanxi Medical University, Shanghai Pulmonary Hospital, Shanghai, China, Tianjin Medical University General Hospital
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxyhydrogen | Experimental | Device: oxyhydrogen, Drug: Conventional treatmentconventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaled |
| oxygen | Experimental | Device: Oxygen, Drug: Conventional treatmentconventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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% ;
- 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;
- the age is over 40 years old and has the normal independent judgment ability patient, the male and the female are not limited;
- AECOPD patients requiring in-patient Care;
- patients with BCSS score ≥6 at the time of admission;
Key exclusion criteria (21 listed)
- 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;
- 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;
- 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) ;
- Lung Rehabilitation: Participants in the Lung Rehabilitation Program during the study period;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxyhydrogenHydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days | Device | oxyhydrogen |
| Oxygenoxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days | Device | oxygen |
| Conventional treatmentBronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in seven days before the study | Drug | oxygen, oxyhydrogen |
Primary outcome
The Breathlessness, Cough, and Sputum Scale(BCSS score)
Time frame: everyday from the baseline to the seventh day
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.
9 secondary outcomes
COPD assessment test (CAT)
Time frame: baseline and the seventh day
FEV1
Time frame: baseline and the seventh day
FVC
Time frame: baseline and the seventh day
FEV1/FVC
Time frame: baseline and the seventh day
PaO2
Time frame: baseline and the seventh day
PaCO2
Time frame: baseline and the seventh day
Potential of Hydrogen
Time frame: baseline and the seventh day
oxygen saturation of blood
Time frame: everyday from the baseline to the seventh day
Results Of Performance Evaluation Of Apparatus
Time frame: everyday from the baseline to the seventh day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 12564612Leidy 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.
- Background: PubMed 14665499Leidy 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.
- Derived from this study: PubMed 33985501Zheng 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.
- Individual participant dataSharing planned: Yes. the main evaluation index and the secondary evaluation index of all participants will be share in 3 months after the end of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxyhydrogen, Oxygen and Conventional treatment in people with Copd Exacerbation Acute, run by Shanghai Asclepius Meditec Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Breathlessness, Cough, and Sputum Scale(BCSS score) (time frame: everyday from the baseline to the seventh day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000451, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.