Adjuvant Therapy for Severe Asthma by an Oxyhydrogen Generator With Nebulizer

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02883582
• Other study ID #: QLZhang
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2016
• Last updated: August 24, 2016
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Shanghai Asclepius Meditec Inc.
• Contact: Qingling Zhang, doctor
• Phone: 13609068871
• Email: zqling68[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Asclepius Meditec Inc.	Second Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 3 months	Yes
Secondary	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.	at 3 months	Yes
Secondary	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.	at 3 months	Yes
Secondary	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.	at 3 months	Yes
Secondary	differentials from airway resistance measurement	The patient airway resistance was measured was measured, including: Rat5Hz, Rat20Hz, Xat5Hz, MeanR5~R20 and AX.	at 3 months	Yes
Secondary	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.	at 3 months	Yes
Secondary	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.	at 3 months	Yes
Secondary	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.	at 3 months	Yes
Secondary	differentials from blood routine examination		at 3 months	Yes
Secondary	differentials from serum C reactive protein (CRP)		at 3 months	Yes
Secondary	differentials from liver function examination		at 3 months	Yes
Secondary	differentials from renal function examination		at 3 months	Yes
Secondary	differentials from electrolyte test		at 3 months	Yes
Secondary	differentials from routine urine test		at 3 months	Yes
Secondary	differentials from 12-lead ECG test		at 3 months	Yes
Secondary	differentials from urine pregnancy test for fertile women		at 3 months	Yes
Secondary	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.	at 3 months	Yes
Secondary	differentials from Baseline in Serum interleukin-6(IL-6)		at 3 months	Yes
Secondary	differentials from Baseline in Serum interleukin-8( IL - 8)		at 3 months	Yes
Secondary	differentials from Baseline in Serum tumor necrosis factor-a(TNF-a)		at 3 months	Yes
Secondary	differentials from Baseline in Serum interleukin-4( IL - 4)		at 3 months	Yes
Secondary	differentials from Baseline in Serum interleukin-5( IL - 5)		at 3 months	Yes
Secondary	differentials from Baseline in Serum interleukin-13( IL - 13)		at 3 months	Yes
Secondary	differentials from Baseline in Serum interleukin-17( IL - 17)		at 3 months	Yes
Secondary	differentials from induced sputum test	proportions of eosinophils, macrophages, lymphocytes, and neutrophils;	at 3 months	Yes