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

Not Applicable

• Conditions: Acute Exacerbation of Bronchiectasis; Oxidative Stress; Bronchiectasis

• 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.

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Study Start: 2016-06-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-01
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

West China Hospital Affiliateyd to Sichuan Universit; 🇨🇳 Chengdu, China

Affiliated Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China