Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer

NCT02850185 | Unknown DMC

• 1 other identifier: ZZheng
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

COPD; hydrogen

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in dyspnea index score (mMRC score) at 3 months

  baseline and 3 months

Secondary Outcomes (15)

• Change from Baseline in St George's respiratory questionnaire (SGRQ score) at 3 months

  baseline and 3 months

• Change from Baseline in Six minute walk distance at 3 months

  baseline and 3 months

• Change from Baseline in Pulmonary artery pressure measured by heart color Doppler ultrasound at 3 months

  baseline and 3 months

• Change from Baseline in Forcibly vital capacity(FVC) at 3 months

  baseline and 3 months

• Change from Baseline in First second forcibly expiration quantity(FEV1) at 3 months

  baseline and 3 months

Study Arms (2)

oxyhydrogen

EXPERIMENTAL

conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaled

Device: oxyhydrogen; Drug: Conventional treatment

oxygen

EXPERIMENTAL

conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled

Device: Oxygen; Drug: Conventional treatment

Interventions

oxyhydrogen DEVICE

Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.

Also known as: Oxyhydrogen generator with nebulizer

oxyhydrogen

Oxygen DEVICE

oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.

Also known as: Medical molecular sieve oxygenerator

oxygen

Conventional treatment DRUG

Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months before the study.

Also known as: medication treatment

oxygen; oxyhydrogen

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; -

You may not qualify if:

• \) 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.
• \) 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.

Sponsors & Collaborators

• Shanghai Asclepius Meditec Inc.: lead
• West China Hospital: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Tianjin Medical University General Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 17486089 BACKGROUND

• Liu 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.

  PMID: 24685114 BACKGROUND

• Kohama 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.

  PMID: 25983276 BACKGROUND

• Nakao 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.

  PMID: 20216947 BACKGROUND

• Xiao 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.

  PMID: 23661516 BACKGROUND

• Ning 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.

  PMID: 24376700 BACKGROUND

• Zheng 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.

  PMID: 20568549 BACKGROUND

• Kawamura 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.

  PMID: 23475767 BACKGROUND

• Huang 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.

  PMID: 21473852 BACKGROUND

• Sun 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.

  PMID: 21067781 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Nebulizers and Vaporizers; Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Respiratory Therapy; Therapeutics

Study Officials

• Zhong N Shan, academician

  First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Zheng Z Guang, doctor

CONTACT

18928868242; zheng862082@139.com

Hu J Ying, master

CONTACT

13544425867; hujieyingjy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: July 15, 2016
• Primary Completion: July 21, 2020
• Study Completion: December 20, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)