Trials / Unknown
UnknownNCT02883582
Adjuvant Therapy for Severe Asthma by an Oxyhydrogen Generator With Nebulizer
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Shanghai Asclepius Meditec Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | oxygen | oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-08-01
- Completion
- 2017-12-01
- First posted
- 2016-08-30
- Last updated
- 2016-08-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02883582. Inclusion in this directory is not an endorsement.