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

Guangzhou Institute of Respiratory Disease120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Bronchiectasis

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).

Medical molecular mesh oxygen generatorDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (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

Outcomes

Primary Outcomes

Frequency of bronchiectasis exacerbations (BEs) within 12 months

Time frame: up to 12 months (1 year)

Secondary Outcomes

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