NCT02765295|UnknownDMC
Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study
HYBRID
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HYBRID
Sponsor study identifier
interventional
120
1 country
5
Study Start
June 1, 2016
Actual (reported)Primary Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a multi-center, randomized, double-blind, parallel-group trial. After a 2-week run-in period, eligible patients will be, based on the randomization codes kept in sealed envelopes, randomly assigned to receive usual care (mucolytics and/or chest physiotherapy) plus oxygen inahaltion (1 hr daily for 12 consecutive months) or hydrogen inhalation (1 hr daily for 12 consecutive months) provided by the sponsor. At 3 months after the end-of-treatment, a follow-up visit will be scheduled for all patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 3, 2016
Actual (reported)May 6, 2016
Actual (reported)June 1, 2016
Actual (reported)December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Frequency of bronchiectasis exacerbations (BEs) within 12 months
Frequency of bronchiectasis exacerbations (BEs) within 12 months
up to 12 months (1 year)
Changes in sputum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
baseline, month 6 and month 12
Time to the first bronchiectasis exacerbations (BEs) within 12 months
up to 12 months
Changes in sputum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
baseline, month 6 and month 12
Changes in serum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
baseline, month 6 and month 12
Changes in serum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
baseline, month 6 and month 12
Changes in airway impedance as measured by impulse oscillometry (Z5, R5, R20, X5, Fres and AX at each visit as compared with baseline
baseline, month 1, month 3, month 6, month 9 and month 12
Changes in dyshomogeneity (lung clearance index) at month 6 and 12 as compared with baseline
baseline, month 6 and month 12
Changes in anaerobic threshold (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline
baseline, month 6 and month 12
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.
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.
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).
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.
Loebinger MR, Wells AU, Hansell DM, Chinyanganya N, Devaraj A, Meister M, Wilson R. Mortality in bronchiectasis: a long-term study assessing the factors influencing survival. Eur Respir J. 2009 Oct;34(4):843-9. doi: 10.1183/09031936.00003709. Epub 2009 Apr 8.
Nan-shan Zhong, MD
Guangzhou Institute of Respiratory Disease
First Submitted
May 3, 2016
First Posted
May 6, 2016
Study Start
June 1, 2016
Actual (reported)Primary Completion
December 2021
Estimated (date passed)Cultural Meal and Postprandial Oxidative Stress
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
West China Hospital Affiliateyd to Sichuan Universit
Chengdu, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2019
Record last verified: 2019-07
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