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

NCT02765295 | Unknown DMC

• 1 other identifier: GWJ-2015-H2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Bronchiectasis; Acute Exacerbation of Bronchiectasis; Oxidative Stress

Keywords

Hydrogen; Inhalation; bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Frequency of bronchiectasis exacerbations (BEs) within 12 months

  Frequency of bronchiectasis exacerbations (BEs) within 12 months

  up to 12 months (1 year)

Secondary Outcomes (8)

• 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

Other Outcomes (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

Study Arms (2)

hydrogen inhalation

ACTIVE COMPARATOR

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)

oxygen inhalation

SHAM COMPARATOR

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

Interventions

medical ultrasonic hydrogen/oxygen nebulizer (MUNHO) DEVICE

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).

Also known as: hydrogen generating instrument

hydrogen inhalation

Medical molecular mesh oxygen generator DEVICE

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.

Also known as: Oxygen generating instrument

oxygen inhalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (5)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

West China Hospital Affiliateyd to Sichuan Universit

Chengdu, China

NOT YET RECRUITING

Affiliated Zhongshan Hospital of Fudan University

Shanghai, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, China

NOT YET RECRUITING

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MeSH Terms

Conditions

Bronchiectasis; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nan-shan Zhong, MD

  Guangzhou Institute of Respiratory Disease

  STUDY CHAIR

Central Study Contacts

Nan-shan Zhong, MD

CONTACT

+86-13609003622; nanshan@vip.163.com

Wei-jie Guan, PhD

CONTACT

+86-13826042052; battery203@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 6, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

CN (5)