Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study
NCT ID: NCT02765295
Last Updated: 2019-08-01
Study Results
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Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2016-06-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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hydrogen inhalation
The medical ultrasonic nebulizers with hydrogen/oxygen generating function (MUNHO) will be provided exclusively by the sponsor, Asclepius Meditec Inc (Shanghai, China). The MUNHO consists of a electrolytic tank which, by using direct current converted from alternating current (220 V), generates the hydrogen and oxygen gas from pure water (2:1 in volume). The MUNHO is also capable of nebulizing the water via ultrasounds with the hydrogen-oxygen mixture gas which is finally delivered to the patient's airways via the facial mask through a plastic tube. Typically, the volume of hydrogen-oxygen mixed gas is 3 liters per minute (3 L/min). Usual care referred to mucolytics (see below for details) alone or plus chest physiotherapy.
medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)
The medical ultrasonic nebulizers with hydrogen/oxygen generating function (MUNHO) will be provided exclusively by the sponsor, Asclepius Meditec Inc (Shanghai, China). The MUNHO consists of a electrolytic tank which, by using direct current converted from alternating current (220 V), generates the hydrogen and oxygen gas from pure water (2:1 in volume). The MUNHO is also capable of nebulizing the water via ultrasounds with the hydrogen-oxygen mixed gas which is finally delivered to the patient's airways via the facial mask through a plastic tube. Typically, the volume of hydrogen-oxygen mixed gas is 3 liters per minute (3 L/min).
oxygen inhalation
Oxygen will be generated by an instrument provided by the sponsor, that would be capable of generating oxygen equivalent to that generated by the MUNHO (3L/min mixed gas containing 33.3% oxygen). Usual care referred to mucolytics \[\[ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily)/ serrapeptase (10mg thrice daily), or carbocisteine (500mg thrice daily)\] alone or in combination with chest physiotherapy.
Medical molecular mesh oxygen generator
medical molecular mesh oxygen generator, type: OLO-1, oxygen flow: 3L/min; Shanghai Ouliang Medical Instrument Inc., Shanghai, China; Registration No.: Shanghai Medical Instrument approval No. 20152540046.
This device has an identical appearance as compared with the MUHNO so that the patients could not readily discriminate with the MUHNO, and is also capable of displaying the actual cumulative duration of oxygen inhalation.
Interventions
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medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)
The medical ultrasonic nebulizers with hydrogen/oxygen generating function (MUNHO) will be provided exclusively by the sponsor, Asclepius Meditec Inc (Shanghai, China). The MUNHO consists of a electrolytic tank which, by using direct current converted from alternating current (220 V), generates the hydrogen and oxygen gas from pure water (2:1 in volume). The MUNHO is also capable of nebulizing the water via ultrasounds with the hydrogen-oxygen mixed gas which is finally delivered to the patient's airways via the facial mask through a plastic tube. Typically, the volume of hydrogen-oxygen mixed gas is 3 liters per minute (3 L/min).
Medical molecular mesh oxygen generator
medical molecular mesh oxygen generator, type: OLO-1, oxygen flow: 3L/min; Shanghai Ouliang Medical Instrument Inc., Shanghai, China; Registration No.: Shanghai Medical Instrument approval No. 20152540046.
This device has an identical appearance as compared with the MUHNO so that the patients could not readily discriminate with the MUHNO, and is also capable of displaying the actual cumulative duration of oxygen inhalation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically stable bronchiectasis, defined as respiratory symptoms and lung function parameters not exceeding normal daily variations and no acute upper respiratory tract infections for 4 consecutive weeks
* Patients with a history of 2 or more bronchiectasis exacerbations (BEs) within the previous 2 years
Exclusion Criteria
* Concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis
* Concomitant chronic obstructive pulmonary disease as the predominant diagnosis
* Treatment with inhaled, oral or systemic antibiotics within 4 weeks
* Type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation
* Females during lactation or pregnancy
* Poor understanding or failure to properly operate the instrument
* Participation in other clinical trials within 3 months.
18 Years
75 Years
ALL
No
Sponsors
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Guangzhou Institute of Respiratory Disease
OTHER
Responsible Party
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Weijie Guan
doctor
Principal Investigators
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Nan-shan Zhong, MD
Role: STUDY_CHAIR
Guangzhou Institute of Respiratory Disease
Locations
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First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
West China Hospital Affiliateyd to Sichuan Universit
Chengdu, , China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Fei-peng Chen
Role: primary
Zong-an Liang
Role: primary
Yuan-lin Song
Role: primary
Jin-fu Xu
Role: primary
References
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Other Identifiers
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GWJ-2015-H2
Identifier Type: -
Identifier Source: org_study_id
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