Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis (HYBRID): A Randomized, Multi-center, Double-blind, Parallel-group Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchiectasis
- Sponsor
- Guangzhou Institute of Respiratory Disease
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- Frequency of bronchiectasis exacerbations (BEs) within 12 months
- Last Updated
- 6 years ago
Overview
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.
Investigators
Weijie Guan
doctor
Guangzhou Institute of Respiratory Disease
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.
Outcomes
Primary Outcomes
Frequency of bronchiectasis exacerbations (BEs) within 12 months
Time Frame: up to 12 months (1 year)
Frequency of bronchiectasis exacerbations (BEs) within 12 months
Secondary Outcomes
- 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)
- Changes in CRP 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(baseline, month 6 and month 12)
- Time to the first bronchiectasis exacerbations (BEs) within 12 months(up to 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 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)