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

Primary Purpose

Bronchiectasis, Acute Exacerbation of Bronchiectasis, Oxidative Stress

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)
Medical molecular mesh oxygen generator
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Hydrogen, Inhalation, bronchiectasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • West China Hospital Affiliateyd to Sichuan Universit
  • Affiliated Zhongshan Hospital of Fudan University
  • Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

hydrogen inhalation

oxygen inhalation

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency of bronchiectasis exacerbations (BEs) within 12 months
Frequency of bronchiectasis exacerbations (BEs) within 12 months

Secondary Outcome Measures

Changes in sputum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
Changes in sputum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
Time to the first bronchiectasis exacerbations (BEs) within 12 months
Time to the first bronchiectasis exacerbations (BEs) within 12 months
Changes in sputum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
Changes in sputum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
Changes in serum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
Changes in serum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
Changes in serum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
Changes in serum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
Changes in spirometry, including FEV1, FEV1/FVC ratio and MMEF at each visit following randomization as compared with baseline
Changes in spirometry, including FEV1, FEV1/FVC ratio and MMEF at each visit following randomization as compared with baseline
Changes in CRP levels at month 6 and 12 as compared with baseline
Changes in CRP levels at month 6 and 12 as compared with baseline
Changes in quality of life assessed by using Quality-of-Life Questionnaire--Bronchiectasis (QoL-B) at month 6 and 12 as compared with baseline
Changes in quality of life assessed by using Quality-of-Life Questionnaire--Bronchiectasis (QoL-B) at month 6 and 12 as compared with baseline

Full Information

First Posted
May 3, 2016
Last Updated
July 31, 2019
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT02765295
Brief Title
Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study
Acronym
HYBRID
Official Title
Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis (HYBRID): A Randomized, Multi-center, Double-blind, Parallel-group Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis, Acute Exacerbation of Bronchiectasis, Oxidative Stress
Keywords
Hydrogen, Inhalation, bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hydrogen inhalation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
oxygen inhalation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)
Other Intervention Name(s)
hydrogen generating instrument
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Medical molecular mesh oxygen generator
Other Intervention Name(s)
Oxygen generating instrument
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of bronchiectasis exacerbations (BEs) within 12 months
Description
Frequency of bronchiectasis exacerbations (BEs) within 12 months
Time Frame
up to 12 months (1 year)
Secondary Outcome Measure Information:
Title
Changes in sputum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
Description
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
Title
Time to the first bronchiectasis exacerbations (BEs) within 12 months
Description
Time to the first bronchiectasis exacerbations (BEs) within 12 months
Time Frame
up to 12 months
Title
Changes in sputum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
Description
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
Title
Changes in serum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline
Description
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
Title
Changes in serum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline
Description
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
Title
Changes in spirometry, including FEV1, FEV1/FVC ratio and MMEF at each visit following randomization as compared with baseline
Description
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
Title
Changes in CRP levels at month 6 and 12 as compared with baseline
Description
Changes in CRP levels at month 6 and 12 as compared with baseline
Time Frame
baseline, month 6 and month 12
Title
Changes in quality of life assessed by using Quality-of-Life Questionnaire--Bronchiectasis (QoL-B) at month 6 and 12 as compared with baseline
Description
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
Other Pre-specified Outcome Measures:
Title
Changes in airway impedance as measured by impulse oscillometry (Z5, R5, R20, X5, Fres and AX at each visit as compared with baseline
Description
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
Title
Changes in dyshomogeneity (lung clearance index) at month 6 and 12 as compared with baseline
Description
Changes in dyshomogeneity (lung clearance index) at month 6 and 12 as compared with baseline
Time Frame
baseline, month 6 and month 12
Title
Changes in anaerobic threshold (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline
Description
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
Title
Changes in oxygen pulse (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline
Description
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
Title
Changes in the difference of arterial and alveolar oxygen partial pressure (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline
Description
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
Title
Changes in carbon dioxide ventilatory equivalent (during cardiopulmonary exercise testing) at month 6 and 12 as compared with baseline
Description
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
Title
Changes in 24-hour sputum volume at each visit as compared with baseline
Description
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
Title
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
Description
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
Title
Changes in sputum matrix metalloproteinases (MMP-8, MMP-9, MMP-9/TIMP-1 ratio) levels at month 6 and 12 as compared with baseline
Description
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
Title
The rates of Pseudomonas aeruginosa isolated from sputum at baseline and end-of-treatment at month 6 and 12 as compared with baseline
Description
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
Title
Sputum microbiota compositions before and after hydrogen therapy
Description
Sputum microbiota compositions before and after hydrogen therapy. This is an exploratory outcome.
Time Frame
up to 12 months (at baseline, month 6, and month 12)
Title
the rate of adverse events
Description
the rate of adverse events
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan-shan Zhong, MD
Phone
+86-13609003622
Email
nanshan@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-jie Guan, PhD
Phone
+86-13826042052
Email
battery203@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan-shan Zhong, MD
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-jie Guan
Email
battery203@163.com
First Name & Middle Initial & Last Name & Degree
Nan-shan Zhong
Email
nanshan@vip.163.com
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei-peng Chen
Facility Name
West China Hospital Affiliateyd to Sichuan Universit
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zong-an Liang
Facility Name
Affiliated Zhongshan Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan-lin Song
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-fu Xu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study

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