Adjuvant Therapy for Severe Asthma by an Oxyhydrogen Generator With Nebulizer

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02883582
• Date of registration: 15/08/2016
• Prospective Registration: No
• Primary sponsor: Shanghai Asclepius Meditec Inc.
• Public title: Adjuvant Therapy for Severe Asthma by an Oxyhydrogen Generator With Nebulizer
• Scientific 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
• Date of first enrolment: August 2016
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02883582
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Nanshan Zhong, academician
• Affiliation: China, Guangdong First Affiliated Hospital of Guangzhou Medical University

• Name: Qingling Zhang, doctor

• Name: Qingling Zhang, doctor

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age range: =18 years old but =65 years old; sex unlimited;

2. 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
as?FEV1.0% at a basis FEV1.0=200mL at 30 minutes after 400µgsalbutamol
aerosol (mist-storing bottle might be used deliberately) was inhaled; ? 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 ?FEV1.0 and its absolute
value=200mL);

3. 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:

- 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); ? Serious
attack: Hospitalizing once in ICU or mechanical ventilation at least in the
past year; ? 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);

4. The subjects or their legal agents could understand the trial objectives,
demonstrating the compliance to the trail scheme, and signed the Informed Consent
Form.

Exclusion Criteria:

1. The subjects at a body mass index>38kg/m2, or a weight<40kg;

2. The subjects' smoking amount>10 packages times the year number (e.g. number of
cigarettes × the number of years for smoking/20);

3. 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;

4. 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;

5. 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;

6. 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;

7. The investigator believed the subjects showed the risk of non-compliance with
research procedures;

8. The subjects had the mental disease history resulting in loss of active ability in
the recent period;

9. 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);

10. The subject changed the asthmatic drugs within four weeks before the screening;

11. 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);

12. 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);

13. Other severe primary pulmonary diseases, especially pulmonary embolism, pulmonary
hypertension, interstitial pulmonary disease and lung cancer;

14. 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;

15. The subjects who were diagnosed with other chronic inflammatory diseases
(inflammatory bowel disease, rheumatoid arthritis) except asthma.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Device: oxygen

Device: oxyhydrogen

Primary Outcome(s)

differentials from Mini Asthma Quality of life questionnaire (Mini AQLQ) [Time Frame: at 3 months]

Secondary Outcome(s)

differentials from renal function examination [Time Frame: at 3 months]

differentials from 12-lead ECG test [Time Frame: at 3 months]

differentials from Special allergens [Time Frame: at 3 months]

differentials from Baseline in Serum interleukin-8( IL - 8) [Time Frame: at 3 months]

differentials from Baseline in Serum tumor necrosis factor-a(TNF-a) [Time Frame: at 3 months]

differentials from blood routine examination [Time Frame: at 3 months]

differentials from liver function examination [Time Frame: at 3 months]

differentials from electrolyte test [Time Frame: at 3 months]

differentials from number of asthma acute attacks [Time Frame: at 3 months]

differentials from asthma control questionnaire [Time Frame: at 3 months]

differentials from Baseline in Serum interleukin-13( IL - 13) [Time Frame: at 3 months]

differentials from airway resistance measurement [Time Frame: at 3 months]

differentials from asthma control test (ACT) [Time Frame: at 3 months]

differentials from induced sputum test [Time Frame: at 3 months]

differentials from pulmonary function [Time Frame: at 3 months]

differentials from routine urine test [Time Frame: at 3 months]

differentials from serum C reactive protein (CRP) [Time Frame: at 3 months]

differentials from Baseline in Serum interleukin-17( IL - 17) [Time Frame: at 3 months]

differentials from Baseline in Serum interleukin-5( IL - 5) [Time Frame: at 3 months]

differentials from Baseline in Serum interleukin-4( IL - 4) [Time Frame: at 3 months]

differentials from Baseline in Serum interleukin-6(IL-6) [Time Frame: at 3 months]

differentials from number of uses of first-aid drugs [Time Frame: at 3 months]

differentials from Peak Expiratory Flow (PEF) daily aberration rate [Time Frame: at 3 months]

differentials from urine pregnancy test for fertile women [Time Frame: at 3 months]

Secondary ID(s)

QLZhang

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The First Affiliated Hospital of Guangzhou Medical University

The Second Hospital of Hebei Medical University

West China Hospital

Second Affiliated Hospital of Guangzhou Medical University

Tianjin Medical University General Hospital