Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study
- Conditions
- Acute Exacerbation of BronchiectasisOxidative StressBronchiectasis
- Interventions
- Device: medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)Device: Medical molecular mesh oxygen generator
- Registration Number
- NCT02765295
- Lead Sponsor
- Guangzhou Institute of Respiratory Disease
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hydrogen inhalation 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 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. oxygen inhalation Medical molecular mesh oxygen generator 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
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
Time to the first bronchiectasis exacerbations (BEs) within 12 months up to 12 months Time to the first bronchiectasis exacerbations (BEs) within 12 months
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
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
Trial Locations
- Locations (5)
First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
West China Hospital Affiliateyd to Sichuan Universit
🇨🇳Chengdu, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China