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

Brief Title

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

Official Title

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

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.
    

Study Type

Interventional

Primary Outcome

Frequency of bronchiectasis exacerbations (BEs) within 12 months

Secondary Outcome

 Changes in sputum oxidant (hydrogen peroxide, reactive oxygen species) levels at month 6 and 12 as compared with baseline

Condition

Bronchiectasis

Intervention

medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)

Study Arms / Comparison Groups

 hydrogen inhalation

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

120

Start Date

June 1, 2016

Completion Date

December 2021

Primary Completion Date

December 2021

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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Nan-shan Zhong, MD, +86-13609003622, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT02765295

Organization ID

GWJ-2015-H2

Responsible Party

Principal Investigator

Study Sponsor

Guangzhou Institute of Respiratory Disease

Study Sponsor

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

Verification Date

July 2019