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 Information
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
Administrative Informations
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