COPDNCT02850185
Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer
A study testing oxyhydrogen, Oxygen and Conventional treatment in people with COPD, 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 an adjuvant therapy for the severe COPD patients in the stable phase. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- 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
- 170 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2016to 20 Dec 2020
- 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
- It conforms to the diagnostic criteria of chronic obstructive pulmonary diseases (COPD): (PFT)The percentage of forced expiratory volume in forced vital capacity in one second after inhaling vasodilator (FEV1 / FVC% < 70%);
- Classification of COPD severity by pulmonary function: The criterion for this study is Severe: FEV1/FVC<0.70, and FEV1< 50% expected value after pulmonary function was examined by taking bronchodilator.
- More than 40 years old and have normal ability to judge independently; men and women are not limited;
- Living in the vicinity of the test centre in the past six months; -
Who cannot join
- 1) Those who have acute exacerbation in the past 4 weeks; 2) Lung disease history: Excluding the history of other lung diseases except combined COPD, such as combined pulmonary tuberculosis and diffuse pan-capillary bronchiolitis, pneumonia, pneumothorax, pleural effusion, pulmonary embolism, etc.
- 3) Those who suffer infectious diseases such as hepatitis A, hepatitis B, AIDS and tuberculosis or connective tissue diseases in the active period; 4) Those who suffer high fever, as well as various local or systemic infections (including respiratory, urinary and reproductive system, digestive system, sepsis, etc.), severe infection, especially lung infection found by CT examination; 5) Those who have limited ability to understand and poor compliance; do not have the legal capacity or limited legal capacity; participated in other clinical trials in the first 3 months when they were included in the groups; mental or physical disability; 6) Those who were difficult to make an exact evaluation on safety and effectiveness of products; 7) The women in pregnancy and lactation, as well as the women at childbearing age who don't agree to take effective contraceptive measures during the study period; 8) Those who have abnormal heart function and thrombophlebitis; 9) Those who are known and can't stand the oxygen and hydrogen inhalation; 10) Those who are suffered from primary diseases in important visceral organs and systems, such as stroke, severe hypertension, gastric ulcer, uncontrolled diabetes, malignant tumor, liver and kidney failure, and severe heart disease history (acute myocardial infarction, congestive heart failure and other heart diseases in the acute phase); 11) Cancer in progressive stage as well as undetermined masses found in the treatment; 12) Those who have one or more lobectomy history; 13) Those who are suspected to have or really have alcohol and drug abuse history; 14) Those whose AST and ALT≥120U/L, Ccr≤50ml/min; who have shock or unstable hemodynamics; 15) Those who are considered not to participate in clinical trials by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Zheng Z Guang, doctor, 86-20-83062843, zheng862080@139.com
Hu J Ying, master, 13544425867, hujieyingjy@126.com
About this study
Official title: Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer: 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 an adjuvant therapy for the severe COPD patients in the stable phase.
Read the detailed description
In this study, severe COPD patients in stable phase who were included in both treatment and control groups, administered randomly oxyhydrogen generator with nebulizer (treatment group) or oxygen Nebulizer Machine （control group ）for adjuvant 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 3 months. The curative effect was observed for subjects in the second week, first month, second month and third month respectively as the observing time point. Total patients which are planned to be included are 140 cases, where, 70 cases in the treatment group and control group respectively are distributed in 5 clinical hospitals.
- Conditions
- COPD
- Being tested
- oxyhydrogen, Oxygen, Conventional treatment
- Keywords
- COPD, hydrogen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxyhydrogenDevice
Also called Oxyhydrogen generator with nebulizer
Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
OxygenDevice
Also called Medical molecular sieve oxygenerator
oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
Conventional treatmentDrug
Also called medication treatment
Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months 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.
Change from Baseline in dyspnea index score (mMRC score) at 3 months
Measured: baseline and 3 months
Secondary outcomes (15)
Change from Baseline in St George's respiratory questionnaire (SGRQ score) at 3 months
Measured: baseline and 3 months
Change from Baseline in Six minute walk distance at 3 months
Measured: baseline and 3 months
Change from Baseline in Pulmonary artery pressure measured by heart color Doppler ultrasound at 3 months
Measured: baseline and 3 months
Change from Baseline in Forcibly vital capacity(FVC) at 3 months
Measured: baseline and 3 months
Change from Baseline in First second forcibly expiration quantity(FEV1) at 3 months
Measured: baseline and 3 months
Change from Baseline in mean maximum expiratory flow(MMEF) at 3 months
Measured: baseline and 3 months
Change from Baseline in Residual volume(RV) at 3 months
Measured: baseline and 3 months
Change from Baseline in Serum interleukin-6(IL-6) at 3 months
Measured: baseline and 3 months
Change from Baseline in Serum interleukin-8( IL - 8) at 3 months
Measured: baseline and 3 months
Change from Baseline in Serum tumor necrosis factor-a(TNF-a) at 3 months
Measured: baseline and 3 months
Change from Baseline in Serum malondialdehyde (MDA) at 3 months
Measured: baseline and 3 months
Change from Baseline in Serum 8-isoprostane at 3 months
Measured: baseline and 3 months
Change from Baseline in Arterial oxygen tension (PaO2) at 3 months
Measured: baseline and 3 months
Change from Baseline in carbon dioxide arterial tension (PaCO2) at 3 months
Measured: baseline and 3 months
number of participants with adverse events
the adverse events including chest distress,wheezing,cough,heartbeat accelerating,abdominal pain,diarrhea,nausea,vomiting,cardiac,liver, renal toxicity , etc.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start15 Jul 2016
- Primary completion21 Jul 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Asclepius Meditec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Second Affiliated Hospital of Guangzhou Medical University, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Ze-guang Zheng, Shanghai Asclepius Meditec Inc.
- Investigators
- Zhong N Shan, academician, Study chair, First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850185
- Sponsor's protocol ID
- ZZheng
- Status last verified
- Apr 2020
- First submitted
- 22 Jul 2016
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. doi: 10.1038/nm1577. Epub 2007 May 7.
PubMed 17486089Liu FT, Xu SM, Xiang ZH, Li XN, Li J, Yuan HB, Sun XJ. Molecular hydrogen suppresses reactive astrogliosis related to oxidative injury during spinal cord injury in rats. CNS Neurosci Ther. 2014 Aug;20(8):778-86. doi: 10.1111/cns.12258. Epub 2014 Mar 31.
PubMed 24685114Kohama K, Yamashita H, Aoyama-Ishikawa M, Takahashi T, Billiar TR, Nishimura T, Kotani J, Nakao A. Hydrogen inhalation protects against acute lung injury induced by hemorrhagic shock and resuscitation. Surgery. 2015 Aug;158(2):399-407. doi: 10.1016/j.surg.2015.03.038. Epub 2015 May 14.
PubMed 25983276Nakao A, Toyoda Y, Sharma P, Evans M, Guthrie N. Effectiveness of hydrogen rich water on antioxidant status of subjects with potential metabolic syndrome-an open label pilot study. J Clin Biochem Nutr. 2010 Mar;46(2):140-9. doi: 10.3164/jcbn.09-100. Epub 2010 Feb 24.
PubMed 20216947Xiao M, Zhu T, Wang T, Wen FQ. Hydrogen-rich saline reduces airway remodeling via inactivation of NF-kappaB in a murine model of asthma. Eur Rev Med Pharmacol Sci. 2013 Apr;17(8):1033-43.
PubMed 23661516Ning Y, Shang Y, Huang H, Zhang J, Dong Y, Xu W, Li Q. Attenuation of cigarette smoke-induced airway mucus production by hydrogen-rich saline in rats. PLoS One. 2013 Dec 20;8(12):e83429. doi: 10.1371/journal.pone.0083429. eCollection 2013.
PubMed 24376700Zheng J, Liu K, Kang Z, Cai J, Liu W, Xu W, Li R, Tao H, Zhang JH, Sun X. Saturated hydrogen saline protects the lung against oxygen toxicity. Undersea Hyperb Med. 2010 May-Jun;37(3):185-92.
PubMed 20568549Kawamura T, Wakabayashi N, Shigemura N, Huang CS, Masutani K, Tanaka Y, Noda K, Peng X, Takahashi T, Billiar TR, Okumura M, Toyoda Y, Kensler TW, Nakao A. Hydrogen gas reduces hyperoxic lung injury via the Nrf2 pathway in vivo. Am J Physiol Lung Cell Mol Physiol. 2013 May 15;304(10):L646-56. doi: 10.1152/ajplung.00164.2012. Epub 2013 Mar 8.
PubMed 23475767Huang CS, Kawamura T, Peng X, Tochigi N, Shigemura N, Billiar TR, Nakao A, Toyoda Y. Hydrogen inhalation reduced epithelial apoptosis in ventilator-induced lung injury via a mechanism involving nuclear factor-kappa B activation. Biochem Biophys Res Commun. 2011 May 6;408(2):253-8. doi: 10.1016/j.bbrc.2011.04.008. Epub 2011 Apr 5.
PubMed 21473852Sun Q, Cai J, Liu S, Liu Y, Xu W, Tao H, Sun X. Hydrogen-rich saline provides protection against hyperoxic lung injury. J Surg Res. 2011 Jan;165(1):e43-9. doi: 10.1016/j.jss.2010.09.024. Epub 2010 Oct 15.
PubMed 21067781
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer: A Multi-centric, Randomized, Parallel-control and Double-blinded Clinic Study
- ClinicalTrials.gov ID
- NCT02850185
- Acronym / sponsor ID
- ZZheng
- Conditions
- COPD
- Keywords
- COPD, hydrogen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Shanghai Asclepius Meditec Inc.Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Second Affiliated Hospital of Guangzhou Medical University, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 15 Jul 2016
- Primary completion
- 21 Jul 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- 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 an adjuvant therapy for the severe COPD patients in the stable phase.
Detailed description
In this study, severe COPD patients in stable phase who were included in both treatment and control groups, administered randomly oxyhydrogen generator with nebulizer (treatment group) or oxygen Nebulizer Machine （control group ）for adjuvant 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 3 months. The curative effect was observed for subjects in the second week, first month, second month and third month respectively as the observing time point. Total patients which are planned to be included are 140 cases, where, 70 cases in the treatment group and control group respectively are distributed in 5 clinical hospitals.
Study design
- Primary purpose
- Other
- 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 (4 listed)
- It conforms to the diagnostic criteria of chronic obstructive pulmonary diseases (COPD): (PFT)The percentage of forced expiratory volume in forced vital capacity in one second after inhaling vasodilator (FEV1 / FVC% < 70%);
- Classification of COPD severity by pulmonary function: The criterion for this study is Severe: FEV1/FVC<0.70, and FEV1< 50% expected value after pulmonary function was examined by taking bronchodilator.
- More than 40 years old and have normal ability to judge independently; men and women are not limited;
- Living in the vicinity of the test centre in the past six months; -
Key exclusion criteria (2 listed)
- 1) Those who have acute exacerbation in the past 4 weeks; 2) Lung disease history: Excluding the history of other lung diseases except combined COPD, such as combined pulmonary tuberculosis and diffuse pan-capillary bronchiolitis, pneumonia, pneumothorax, pleural effusion, pulmonary embolism, etc.
- 3) Those who suffer infectious diseases such as hepatitis A, hepatitis B, AIDS and tuberculosis or connective tissue diseases in the active period; 4) Those who suffer high fever, as well as various local or systemic infections (including respiratory, urinary and reproductive system, digestive system, sepsis, etc.), severe infection, especially lung infection found by CT examination; 5) Those who have limited ability to understand and poor compliance; do not have the legal capacity or limited legal capacity; participated in other clinical trials in the first 3 months when they were included in the groups; mental or physical disability; 6) Those who were difficult to make an exact evaluation on safety and effectiveness of products; 7) The women in pregnancy and lactation, as well as the women at childbearing age who don't agree to take effective contraceptive measures during the study period; 8) Those who have abnormal heart function and thrombophlebitis; 9) Those who are known and can't stand the oxygen and hydrogen inhalation; 10) Those who are suffered from primary diseases in important visceral organs and systems, such as stroke, severe hypertension, gastric ulcer, uncontrolled diabetes, malignant tumor, liver and kidney failure, and severe heart disease history (acute myocardial infarction, congestive heart failure and other heart diseases in the acute phase); 11) Cancer in progressive stage as well as undetermined masses found in the treatment; 12) Those who have one or more lobectomy history; 13) Those who are suspected to have or really have alcohol and drug abuse history; 14) Those whose AST and ALT≥120U/L, Ccr≤50ml/min; who have shock or unstable hemodynamics; 15) Those who are considered not to participate in clinical trials by the investigators.
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 |
|---|---|---|
| oxyhydrogenAlso: Oxyhydrogen generator with nebulizerHydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months. | Device | oxyhydrogen |
| OxygenAlso: Medical molecular sieve oxygeneratoroxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months. | Device | oxygen |
| Conventional treatmentAlso: medication treatmentBronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months before the study. | Drug | oxygen, oxyhydrogen |
Primary outcome
Change from Baseline in dyspnea index score (mMRC score) at 3 months
Time frame: baseline and 3 months
15 secondary outcomes
Change from Baseline in St George's respiratory questionnaire (SGRQ score) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Six minute walk distance at 3 months
Time frame: baseline and 3 months
Change from Baseline in Pulmonary artery pressure measured by heart color Doppler ultrasound at 3 months
Time frame: baseline and 3 months
Change from Baseline in Forcibly vital capacity(FVC) at 3 months
Time frame: baseline and 3 months
Change from Baseline in First second forcibly expiration quantity(FEV1) at 3 months
Time frame: baseline and 3 months
Change from Baseline in mean maximum expiratory flow(MMEF) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Residual volume(RV) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum interleukin-6(IL-6) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum interleukin-8( IL - 8) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum tumor necrosis factor-a(TNF-a) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum malondialdehyde (MDA) at 3 months
Time frame: baseline and 3 months
Change from Baseline in Serum 8-isoprostane at 3 months
Time frame: baseline and 3 months
Change from Baseline in Arterial oxygen tension (PaO2) at 3 months
Time frame: baseline and 3 months
Change from Baseline in carbon dioxide arterial tension (PaCO2) at 3 months
Time frame: baseline and 3 months
number of participants with adverse events
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Background: PubMed 17486089Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. doi: 10.1038/nm1577. Epub 2007 May 7.
- Background: PubMed 24685114Liu FT, Xu SM, Xiang ZH, Li XN, Li J, Yuan HB, Sun XJ. Molecular hydrogen suppresses reactive astrogliosis related to oxidative injury during spinal cord injury in rats. CNS Neurosci Ther. 2014 Aug;20(8):778-86. doi: 10.1111/cns.12258. Epub 2014 Mar 31.
- Background: PubMed 25983276Kohama K, Yamashita H, Aoyama-Ishikawa M, Takahashi T, Billiar TR, Nishimura T, Kotani J, Nakao A. Hydrogen inhalation protects against acute lung injury induced by hemorrhagic shock and resuscitation. Surgery. 2015 Aug;158(2):399-407. doi: 10.1016/j.surg.2015.03.038. Epub 2015 May 14.
- Background: PubMed 20216947Nakao A, Toyoda Y, Sharma P, Evans M, Guthrie N. Effectiveness of hydrogen rich water on antioxidant status of subjects with potential metabolic syndrome-an open label pilot study. J Clin Biochem Nutr. 2010 Mar;46(2):140-9. doi: 10.3164/jcbn.09-100. Epub 2010 Feb 24.
- Background: PubMed 23661516Xiao M, Zhu T, Wang T, Wen FQ. Hydrogen-rich saline reduces airway remodeling via inactivation of NF-kappaB in a murine model of asthma. Eur Rev Med Pharmacol Sci. 2013 Apr;17(8):1033-43.
- Background: PubMed 24376700Ning Y, Shang Y, Huang H, Zhang J, Dong Y, Xu W, Li Q. Attenuation of cigarette smoke-induced airway mucus production by hydrogen-rich saline in rats. PLoS One. 2013 Dec 20;8(12):e83429. doi: 10.1371/journal.pone.0083429. eCollection 2013.
- Background: PubMed 20568549Zheng J, Liu K, Kang Z, Cai J, Liu W, Xu W, Li R, Tao H, Zhang JH, Sun X. Saturated hydrogen saline protects the lung against oxygen toxicity. Undersea Hyperb Med. 2010 May-Jun;37(3):185-92.
- Background: PubMed 23475767Kawamura T, Wakabayashi N, Shigemura N, Huang CS, Masutani K, Tanaka Y, Noda K, Peng X, Takahashi T, Billiar TR, Okumura M, Toyoda Y, Kensler TW, Nakao A. Hydrogen gas reduces hyperoxic lung injury via the Nrf2 pathway in vivo. Am J Physiol Lung Cell Mol Physiol. 2013 May 15;304(10):L646-56. doi: 10.1152/ajplung.00164.2012. Epub 2013 Mar 8.
- Background: PubMed 21473852Huang CS, Kawamura T, Peng X, Tochigi N, Shigemura N, Billiar TR, Nakao A, Toyoda Y. Hydrogen inhalation reduced epithelial apoptosis in ventilator-induced lung injury via a mechanism involving nuclear factor-kappa B activation. Biochem Biophys Res Commun. 2011 May 6;408(2):253-8. doi: 10.1016/j.bbrc.2011.04.008. Epub 2011 Apr 5.
- Background: PubMed 21067781Sun Q, Cai J, Liu S, Liu Y, Xu W, Tao H, Sun X. Hydrogen-rich saline provides protection against hyperoxic lung injury. J Surg Res. 2011 Jan;165(1):e43-9. doi: 10.1016/j.jss.2010.09.024. Epub 2010 Oct 15.
- 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.
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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.
Zhong N Shan, academician study chair
First Affiliated Hospital of Guangzhou Medical University
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, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Z Guang, doctor (18928868242, zheng862082@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in dyspnea index score (mMRC score) at 3 months (time frame: baseline and 3 months). 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 NCT02850185, which also lists 10 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 2 Apr 2020.