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

• Sponsor: Guangzhou Institute of Respiratory Disease (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02765295
• Collaborator: (none)
• Enrollment: 120
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 66
• Patients Per Site: 24
• Patients Per Site Per Month: 0.4

Study Details

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.

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Jun 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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 Names: 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 Names: Oxygen generating instrument

Outcome Measures

Primary Outcome Measures

1. Frequency of bronchiectasis exacerbations (BEs) within 12 months [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [up to 12 months]

    the rate of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
2	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
3	West China Hospital Affiliateyd to Sichuan Universit	Chengdu		China
4	Affiliated Zhongshan Hospital of Fudan University	Shanghai		China
5	Shanghai Pulmonary Hospital	Shanghai		China

Sponsors and Collaborators

• Guangzhou Institute of Respiratory Disease

Investigators

• Study Chair: Nan-shan Zhong, MD, Guangzhou Institute of Respiratory Disease

Study Documents (Full-Text)

None provided.

More Information

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
• Last Update Posted: Aug 1, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Weijie Guan, doctor, Guangzhou Institute of Respiratory Disease: Hydrogen; Inhalation; bronchiectasis
• Additional relevant MeSH terms: Respiratory Aspiration; Bronchiectasis

Study Results

No Results Posted as of Aug 1, 2019