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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02765295
• Date of registration: 03/05/2016
• Prospective Registration: Yes
• Primary sponsor: Guangzhou Institute of Respiratory Disease
• Public title: Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study HYBRID
• Scientific title: Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis (HYBRID): A Randomized, Multi-center, Double-blind, Parallel-group Study
• Date of first enrolment: June 1, 2016
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02765295
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Nan-shan Zhong, MD
• Affiliation: Guangzhou Institute of Respiratory Disease

• Name: Nan-shan Zhong, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Oxidative Stress

Acute Exacerbation of Bronchiectasis

Bronchiectasis

Intervention(s)

Device: medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)

Device: Medical molecular mesh oxygen generator

Primary Outcome(s)

Frequency of bronchiectasis exacerbations (BEs) within 12 months [Time Frame: up to 12 months (1 year)]

Secondary Outcome(s)

Changes in CRP levels at month 6 and 12 as compared with baseline [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 Frame: baseline, month 6 and month 12]

Changes in spirometry, including FEV1, FEV1/FVC ratio and MMEF at each visit following randomization as compared with baseline [Time Frame: baseline, month 1, month 3, month 6, month 9 and month 12]

Changes in sputum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline [Time Frame: baseline, month 6 and month 12]

Time to the first bronchiectasis exacerbations (BEs) within 12 months [Time Frame: up to 12 months]

Changes in serum antioxidants levels (catalase, superoxide dismutase and total antioxidant capacity) at month 6 and 12 as compared with baseline [Time Frame: baseline, month 6 and month 12]

Secondary ID(s)

GWJ-2015-H2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors