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AsthmaNCT02883582

Adjuvant Therapy for Severe Asthma by an Oxyhydrogen Generator With Nebulizer

A study testing oxyhydrogen and oxygen in people with Asthma, run by Shanghai Asclepius Meditec Inc. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose for the trial is intended to evaluate safety and effectiveness of an oxyhydrogen generator with nebulizer in an adjuvant therapy for patients with severe asthma. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
oxyhydrogen and oxygen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
Aug 2016to Dec 2017
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range: ≥18 years old but ≤65 years old; sex unlimited;
  • The subjects were required to be suffered with asthma for 6 months at least by clinical diagnosis by the respirologist based on the international standards (GINA2012).There was the support of one of the following objective evidences in screening and treatment or five years before the treatment:
  • It was the positive reaction in the methacholine provocative test (for the patients not applied with inhaled corticosteroid (ICS) were required at PC20<8mg/mL and PD20<0.7mg; for the patients applied with ICS were required at PC20<16mg/mL or PD20<1.4mg);
  • The airway reversibility test, with a positive reaction, was defined asΔFEV1.0% at a basis FEV1.0≥200mL at 30 minutes after 400μgsalbutamol aerosol (mist-storing bottle might be used deliberately) was inhaled; ③ The peak expiratory flow (PEF) aberration rate>20% (that is, the difference or average value of maximum and minimum PEFs times 100); it was measured for seven days successively;
  • The reaction record after asthma maintenance treatment for one course of treatment (e.g. four weeks) (defined as ΔFEV1.0 and its absolute value≥200mL);
  • According with severe asthma diagnosis: The drug therapy was required for Level-4 and 5 asthma according to GINA Guide in the past year (The large dose of ICS combined LABA or leukotriene modifier/theophyline), or the systemic corticosteroid treatment lasted at ≥50% of the time to prevent from the "uncontrollable" asthma; or the "uncontrollable" asthma still occurred even if in above treatment. The uncontrollable asthma should meet one of the following requirements at least:
Show all 9Show fewer
  • Symptom control difference: ACQ>1.5, and ACT<20 (or "Non-good control" in GINA Guide);
  • Frequent severe attack: Receiving systemic corticosteroid treatment for more than twice in the past year (over three days each time); ③ Serious attack: Hospitalizing once in ICU or mechanical ventilation at least in the past year; ④ Airway limitation: After bronchodilator was stopped properly, FEVl.0%<80% (FEV/FVC decreased to be less than lower limit of the normal value). The controlled asthma deteriorated at the decrement of above large dose ICS or systemic corticosteroid (or combined biologic agent);
  • The subjects or their legal agents could understand the trial objectives, demonstrating the compliance to the trail scheme, and signed the Informed Consent Form.

Who cannot join

  • The subjects at a body mass index>38kg/m2, or a weight<40kg;
  • The subjects' smoking amount>10 packages times the year number (e.g. number of cigarettes × the number of years for smoking/20);
  • Based on clinical interview, experience or screening inspection results, the subjects should participate in this trial improperly if the doctor responsible for the trial believed there was risk when they participated in the trial, or the research results were affected;
  • The subjects who had the recreational drug abuse history or other allergic history, but the doctor responsible for the trial believed these subjects limited by the history could participated in the trial;
  • The women subjects who were in the pregnancy or suckling period, or six weeks at least after delivery, or stopped breastfeeding for six weeks. If the women subjects were found to be pregnant in receiving one inspection, then, the inspection data for this item should be rejected in analysis;
  • The subjects ever participated in the study on a new drug or any other drugs, and were within 3 months for the first administration, or every participated in one research involved in invasive operation within 3 months. Any research evaluation should be put off to three months later in the first administration or invasive operation when they participated in the research. It was approved by the steering committee if the subjects participating in other researches were included in trial groups or continued participating in this research;
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  • The investigator believed the subjects showed the risk of non-compliance with research procedures;
  • The subjects had the mental disease history resulting in loss of active ability in the recent period;
  • The following disease history or evidences demonstrated within two weeks in baseline assessment that the subjects suffered upper or lower respiratory infections or related symptoms (including common cold) (the assessment should be put off);
  • The subject changed the asthmatic drugs within four weeks before the screening;
  • The subject suffered the asthma attack in the month prior (administered with systemic corticosteroid or temporarily increasing oral corticosteroid at three days of stable base dose at least);
  • Other important diagnoses possibly similar to asthma or complicated asthma, especially respiratory dysfunction, panic attack and evident social psychological problems (if these diagnoses were seen as the patient's main symptoms rather than the symptoms except severe asthma);
  • Other severe primary pulmonary diseases, especially pulmonary embolism, pulmonary hypertension, interstitial pulmonary disease and lung cancer;
  • The subjects with emphysema and bronchiectasis should be excluded only when these diagnoses are considered as their main symptoms rather than other symptoms except severe asthma;
  • The subjects who were diagnosed with other chronic inflammatory diseases (inflammatory bowel disease, rheumatoid arthritis) except asthma.

Trial locations and contacts

1 site in 1 country.

Qingling Zhang, doctor contact

13609068871

zqling68@hotmail.com

Minzhi Qiu, master contact

15915777246

qmz1989111@sina.com

China1 site, 1 recruiting

  • the First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Qingling Zhang, doctor, 13609068871, zqling68@hotmail.com

    Minzhi Qiu, master, 15915777246, qmz1989111@sina.com

    Recruiting

Other trials in China

About this study

Official title: Adjuvant Therapy for Severe Asthma by an Oxyhydrogen Generator With Nebulizer: A Multi-centric, Randomized, Parallel-control and Double-blinded Clinic Study on Effectiveness and Safety

The purpose for the trial is intended to evaluate safety and effectiveness of an oxyhydrogen generator with nebulizer in an adjuvant therapy for patients with severe asthma.

Read the detailed description

The oxyhydrogen generator with nebulizer in (treatment group) or control group was applied randomly for the patients with severe asthma in this study, then the therapeutic effects from both treatment and control groups were analyzed and evaluated to verify its safety and effectiveness.This study is a multi-center, randomized, double-blind study. Each patient was expected to participate in the trial for 104±3 day.The screening period was 14±1 days, and the subjects would continue to be applied with the previous asthma treatment scheme. The primary objective was to collect the baseline data related to the subjects.The patients would receive 30±1 day of treatment with the product; after that, observation of 60±1 days was required.Total patients number is 150 cases, of which 75 cases are treatment group and the others are control group.All cases respectively are distributed in 5 clinical hospitals.

Conditions
Asthma
Being tested
oxyhydrogen, oxygen
Keywords
asthma ,hydrogen
Medical subject headings
Asthma

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.

Study groups in NCT02883582
Study groupRoleWhat they receive
oxyhydrogenExperimentalconventional treatment (bronchodilator (LABA,LAMA)with or without ICS)+ hydrogen/ oxygen inhaled
Receives: Device: oxyhydrogen
oxygenExperimentalconventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled
Receives: Device: oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. differentials from Mini Asthma Quality of life questionnaire (Mini AQLQ)

    Mini Asthma Quality of life questionnaire (Mini AQLQ) was used for evaluation on asthma treatment after the subjects were treated, to determine the product effectiveness.

    Measured: at 3 months

Secondary outcomes (24)

  1. differentials from asthma control questionnaire

    the asthma control questionnaire (ACQ) was used for the evaluation on the subjects' asthma state after treatment, to determine effectiveness of the product.

    Measured: at 3 months

  2. differentials from asthma control test (ACT)

    The asthma control test (ACT) is used for evaluation of the asthma state after treatment, to determine effectiveness of the product.

    Measured: at 3 months

  3. differentials from Peak Expiratory Flow (PEF) daily aberration rate

    Peak Expiratory Flow (PEF) refers to the instant flow rate in the fastest expiratory flow in the forced vital capacity measurement process, mainly reflecting the strength of respiratory flow and airway obstruction.

    Measured: at 3 months

  4. differentials from airway resistance measurement

    The patient airway resistance was measured was measured, including: Rat5Hz, Rat20Hz, Xat5Hz, MeanR5~R20 and AX.

    Measured: at 3 months

  5. differentials from number of asthma acute attacks

    The number of asthma acute attacks refers to the total number of the patient's asthma acute attacks in the observation period after the completion of hydrogen treatment.

    Measured: at 3 months

  6. differentials from number of uses of first-aid drugs

    Number of uses of first aid drugs (short-term beta receptor stimulant) refers to the total number of administering salbutamol for relieving symptoms in the efficacy observation period after each subject completed hydrogen treatment.

    Measured: at 3 months

  7. differentials from Special allergens

    egg white, milk, fish, wheat, peanut, soybean (fx5); house dust, household dust mites, dust mites, cockroaches (hx2); Penicillium notatum/branch neurospora/Aspergillus fumigatus/Candida yeast/Alternaria neurospora/creep cinerea (mx2); inhaled allergen screening (Phadiatop); total IgE1.

    Measured: at 3 months

  8. differentials from blood routine examination

    Measured: at 3 months

  9. differentials from serum C reactive protein (CRP)

    Measured: at 3 months

  10. differentials from liver function examination

    Measured: at 3 months

  11. differentials from renal function examination

    Measured: at 3 months

  12. differentials from electrolyte test

    Measured: at 3 months

  13. differentials from routine urine test

    Measured: at 3 months

  14. differentials from 12-lead ECG test

    Measured: at 3 months

  15. differentials from urine pregnancy test for fertile women

    Measured: at 3 months

  16. differentials from pulmonary function

    Inspection items for patient pulmonary function include: FEV1.0, FEV1.0%, FVC, MMEF, MEF25, MEF50, MEF75, DLCO / VA, PEF †, FeNO, RV, TLC, RV / TLC, and FRC.

    Measured: at 3 months

  17. differentials from Baseline in Serum interleukin-6(IL-6)

    Measured: at 3 months

  18. differentials from Baseline in Serum interleukin-8( IL - 8)

    Measured: at 3 months

  19. differentials from Baseline in Serum tumor necrosis factor-a(TNF-a)

    Measured: at 3 months

  20. differentials from Baseline in Serum interleukin-4( IL - 4)

    Measured: at 3 months

  21. differentials from Baseline in Serum interleukin-5( IL - 5)

    Measured: at 3 months

  22. differentials from Baseline in Serum interleukin-13( IL - 13)

    Measured: at 3 months

  23. differentials from Baseline in Serum interleukin-17( IL - 17)

    Measured: at 3 months

  24. differentials from induced sputum test

    proportions of eosinophils, macrophages, lymphocytes, and neutrophils;

    Measured: at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02883582
Sponsor's protocol ID
QLZhang
Status last verified
Aug 2016
First submitted
15 Aug 2016
Last updated
30 Aug 2016
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

  • Sistek D, Tschopp JM, Schindler C, Brutsche M, Ackermann-Liebrich U, Perruchoud AP, Leuenberger P. Clinical diagnosis of current asthma: predictive value of respiratory symptoms in the SAPALDIA study. Swiss Study on Air Pollution and Lung Diseases in Adults. Eur Respir J. 2001 Feb;17(2):214-9. doi: 10.1183/09031936.01.17202140.

    PubMed 11334122

  • Holgate ST. Pathogenesis of asthma. Clin Exp Allergy. 2008 Jun;38(6):872-97. doi: 10.1111/j.1365-2222.2008.02971.x.

    PubMed 18498538

  • Sears MR. The definition and diagnosis of asthma. Allergy. 1993;48(17 Suppl):12-6; discussion 22-3. doi: 10.1111/j.1398-9995.1993.tb04692.x.

    PubMed 8109702

  • Hines SA. A Weekly Spark for Progressive Educators: Annie Murphy Paul's Brilliant Blog and Newsletter. J Microbiol Biol Educ. 2014 May 1;15(1):63-4. doi: 10.1128/jmbe.v15i1.716. eCollection 2014 May. No abstract available.

    PubMed 24839527

  • Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12.

    PubMed 24337046

  • Sly RM. Mortality from asthma. J Allergy Clin Immunol. 1989 Oct;84(4 Pt 1):421-34. doi: 10.1016/0091-6749(89)90351-5. No abstract available.

    PubMed 2677091

  • Bhavsar P, Hew M, Khorasani N, Torrego A, Barnes PJ, Adcock I, Chung KF. Relative corticosteroid insensitivity of alveolar macrophages in severe asthma compared with non-severe asthma. Thorax. 2008 Sep;63(9):784-90. doi: 10.1136/thx.2007.090027. Epub 2008 May 20.

    PubMed 18492738

  • Juniper EF, Guyatt GH, Ferrie PJ, Griffith LE. Measuring quality of life in asthma. Am Rev Respir Dis. 1993 Apr;147(4):832-8. doi: 10.1164/ajrccm/147.4.832.

    PubMed 8466117

  • Hew M, Bhavsar P, Torrego A, Meah S, Khorasani N, Barnes PJ, Adcock I, Chung KF. Relative corticosteroid insensitivity of peripheral blood mononuclear cells in severe asthma. Am J Respir Crit Care Med. 2006 Jul 15;174(2):134-41. doi: 10.1164/rccm.200512-1930OC. Epub 2006 Apr 13.

    PubMed 16614347

  • Wood LG, Gibson PG, Garg ML. Biomarkers of lipid peroxidation, airway inflammation and asthma. Eur Respir J. 2003 Jan;21(1):177-86. doi: 10.1183/09031936.03.00017003a.

    PubMed 12570126

  • Murata K, Fujimoto K, Kitaguchi Y, Horiuchi T, Kubo K, Honda T. Hydrogen peroxide content and pH of expired breath condensate from patients with asthma and COPD. COPD. 2014 Feb;11(1):81-7. doi: 10.3109/15412555.2013.830094. Epub 2013 Oct 10.

    PubMed 24111595

  • Montuschi P, Corradi M, Ciabattoni G, Nightingale J, Kharitonov SA, Barnes PJ. Increased 8-isoprostane, a marker of oxidative stress, in exhaled condensate of asthma patients. Am J Respir Crit Care Med. 1999 Jul;160(1):216-20. doi: 10.1164/ajrccm.160.1.9809140.

    PubMed 10390403

  • Zayasu K, Sekizawa K, Okinaga S, Yamaya M, Ohrui T, Sasaki H. Increased carbon monoxide in exhaled air of asthmatic patients. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1140-3. doi: 10.1164/ajrccm.156.4.96-08056.

    PubMed 9351613

  • Wood LG, Garg ML, Simpson JL, Mori TA, Croft KD, Wark PA, Gibson PG. Induced sputum 8-isoprostane concentrations in inflammatory airway diseases. Am J Respir Crit Care Med. 2005 Mar 1;171(5):426-30. doi: 10.1164/rccm.200408-1010OC. Epub 2004 Dec 3.

    PubMed 15579724

  • 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 17486089

Questions about this trial

What is this clinical trial studying?

A study testing oxyhydrogen and oxygen in people with Asthma, 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 9 inclusion and 15 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 30 Aug 2016. 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 Qingling Zhang, doctor (13609068871, zqling68@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

differentials from Mini Asthma Quality of life questionnaire (Mini AQLQ) (time frame: at 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 NCT02883582, which also lists 27 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 30 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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