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Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study (HYBRID)

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ClinicalTrials.gov Identifier: NCT02765295
Recruitment Status : Unknown
Verified July 2019 by Weijie Guan, Guangzhou Institute of Respiratory Disease.
Recruitment status was:  Recruiting
First Posted : May 6, 2016
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Weijie Guan, Guangzhou Institute of Respiratory Disease

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Acute Exacerbation of Bronchiectasis Oxidative Stress Device: medical ultrasonic hydrogen/oxygen nebulizer (MUNHO) Device: Medical molecular mesh oxygen generator Not Applicable

Detailed Description:
This is a multi-center, randomized, double-blind, parallel-group trial. After 2-week run-in period, eligible patients will be, based on the randomization codes kept in sealed envelopes, randomly assigned to two groups.On the basis of usual care [ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily)/ serrapeptase (10mg thrice daily), or carbocisteine (500mg thrice daily) and/or chest physiotherapy (10 min, twice daily)], patients were randomized to receive either hydrogen (66.7%, 3L/min, 1 hr twice daily) inhalation or oxygen inhalation (3L/min, 1 hr twice daily) via nasal canula for 12 months. A follow-up visit at month 3 following end-of-treatment was also scheduled. The primary endpoint was the annual frequency of bronchiectasis exacerbations. Hospital visits were scheduled at baseline and months 1, 3, 6, 9, 12 and 15, respectively. At 3 months after the end-of-treatment, a follow-up visit will be scheduled for all patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis (HYBRID): A Randomized, Multi-center, Double-blind, Parallel-group Study
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: 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).
Other Name: hydrogen generating instrument
Sham Comparator: 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.
 Device: 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 Name: Oxygen generating instrument


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of bronchiectasis exacerbations (BEs) within 12 months [ Time Frame: up to 12 months (1 year) ]
    Frequency of bronchiectasis exacerbations (BEs) within 12 months


Secondary Outcome Measures :
  1. Changes in sputum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in sputum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline

  2. Time to the first bronchiectasis exacerbations (BEs) within 12 months [ Time Frame: up to 12 months ]
    Time to the first bronchiectasis exacerbations (BEs) within 12 months

  3. Changes in sputum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in sputum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline

  4. Changes in serum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline [ Time Frame: 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

  5. Changes in serum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline [ Time Frame: 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

  6. Changes in spirometry, including FEV1, FEV1/FVC ratio and MMEF at each visit following randomization as compared with baseline [ Time Frame: baseline, month 1, month 3, month 6, month 9 and month 12 ]
    Changes in spirometry, including FEV1, FEV1/FVC ratio and MMEF at each visit following randomization as compared with baseline

  7. Changes in CRP levels at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in CRP levels at month 6 and 12 as compared with baseline

  8. Changes in quality of life assessed by using Quality-of-Life Questionnaire--Bronchiectasis (QoL-B) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in quality of life assessed by using Quality-of-Life Questionnaire--Bronchiectasis (QoL-B) at month 6 and 12 as compared with baseline


Other Outcome Measures:
  1. Changes in airway impedance as measured by impulse oscillometry (Z5, R5, R20, X5, Fres and AX at each visit as compared with baseline [ Time Frame: baseline, month 1, month 3, month 6, month 9 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

  2. Changes in dyshomogeneity (lung clearance index) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in dyshomogeneity (lung clearance index) at month 6 and 12 as compared with baseline

  3. Changes in anaerobic threshold (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in anaerobic threshold (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline

  4. Changes in oxygen pulse (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in oxygen pulse (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline

  5. Changes in the difference of arterial and alveolar oxygen partial pressure (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in the difference of arterial and alveolar oxygen partial pressure (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline

  6. Changes in carbon dioxide ventilatory equivalent (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in carbon dioxide ventilatory equivalent (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline

  7. Changes in 24-hour sputum volume at each visit as compared with baseline [ Time Frame: baseline, month 1, month 3, month 6, month 9 and month 12 ]
    Changes in 24-hour sputum volume at each visit as compared with baseline

  8. Changes in the levels of sputum inflammatory markers (interleukin-6, interleukin-8 and tumor necrosis factor-α) at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in the levels of sputum inflammatory markers (interleukin-6, interleukin-8 and tumor necrosis factor-α) at month 6 and 12 as compared with baseline

  9. Changes in sputum matrix metalloproteinases (MMP-8, MMP-9, MMP-9/TIMP-1 ratio) levels at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    Changes in sputum matrix metalloproteinases (MMP-8, MMP-9, MMP-9/TIMP-1 ratio) levels at month 6 and 12 as compared with baseline

  10. The rates of Pseudomonas aeruginosa isolated from sputum at baseline and end-of-treatment at month 6 and 12 as compared with baseline [ Time Frame: baseline, month 6 and month 12 ]
    The rates of Pseudomonas aeruginosa isolated from sputum at baseline and end-of-treatment at month 6 and 12 as compared with baseline

  11. Sputum microbiota compositions before and after hydrogen therapy [ Time Frame: up to 12 months (at baseline, month 6, and month 12) ]
    Sputum microbiota compositions before and after hydrogen therapy. This is an exploratory outcome.

  12. the rate of adverse events [ Time Frame: up to 12 months ]
    the rate of adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Out-patients of either gender, ex- or never-smokers, aged between 18 and 75 years
  • 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:

  • Other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction)
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765295


Contacts
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Contact: Nan-shan Zhong, MD +86-13609003622 nanshan@vip.163.com
Contact: Wei-jie Guan, PhD +86-13826042052 battery203@163.com

Locations
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China, Guangdong
First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Wei-jie Guan       battery203@163.com   
Contact: Nan-shan Zhong       nanshan@vip.163.com   
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Fei-peng Chen         
China
West China Hospital Affiliateyd to Sichuan Universit Not yet recruiting
Chengdu, China
Contact: Zong-an Liang         
Affiliated Zhongshan Hospital of Fudan University Not yet recruiting
Shanghai, China
Contact: Yuan-lin Song         
Shanghai Pulmonary Hospital Not yet recruiting
Shanghai, China
Contact: Jin-fu Xu         
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
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Study Chair: Nan-shan Zhong, MD Guangzhou Institute of Respiratory Disease
More Information
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Publications:

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Responsible Party: Weijie Guan, doctor, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT02765295    
Other Study ID Numbers: GWJ-2015-H2
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Weijie Guan, Guangzhou Institute of Respiratory Disease:
Hydrogen
Inhalation
bronchiectasis
Additional relevant MeSH terms:
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Respiratory Aspiration
Bronchiectasis
Respiration Disorders
 Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases