Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer
NCT02850185 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2020-04-02
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
Interventions
- 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.
- DRUG
-
Conventional treatment
Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months before the study.
Sponsors & Collaborators
-
West China Hospital
collaborator OTHER -
Second Affiliated Hospital of Guangzhou Medical University
collaborator OTHER -
The Second Hospital of Hebei Medical University
collaborator OTHER -
Tianjin Medical University General Hospital
collaborator OTHER -
The First Affiliated Hospital of Guangzhou Medical University
collaborator OTHER -
Shanghai Asclepius Meditec Inc.
lead INDUSTRY
Principal Investigators
-
Zhong N Shan, academician · First Affiliated Hospital of Guangzhou Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-15
- Primary Completion
- 2020-07-21
- Completion
- 2020-12-20
Countries
- China
Study Locations
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