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A Prospective, Multicenter, Real-World Clinical Study on the Use of Hydrogen-Oxygen Generator with Nebulizer for Short-Term and Long-Term Auxiliary Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

A Prospective, Multicenter, Real-World Clinical Study on the Use of Hydrogen-Oxygen Generator with Nebulizer for Short-Term and Long-Term Auxiliary Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070422
Enrollment
Unknown
Registered
2023-04-11
Start date
2023-04-11
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Interventions

Experimental group:Received auxiliary treatment with Hydrogen-Oxygen Generator with Nebulizer

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. Subjects with clinically confirmed AECOPD; 3. Use hydrogen and oxygen atomizer for auxiliary treatment; 4. Participate in the study voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with known intolerance to inhalation therapy; 2. Subjects with mental illness or moderate or above disability; 3. Pregnant or lactating female subjects; 4. Subjects assessed by the researcher as unfit to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of device-related adverse events within 12 months of treatment;Change of BCSS score from baseline;

Secondary

MeasureTime frame
The number of acute exacerbations within 12 months of treatment;Time from baseline to the first acute exacerbation;Change of COPD Assessment Test (CAT) score from baseline;Changes in pulmonary function indicators (FVC, FEV1, FEV1/FVC, and PEF) from baseline;Change in 6 Minutes Walking Distance (6MWD) from baseline;Times and days of inpatient/outpatient treatment of AECOPD;

Countries

China

Contacts

Public ContactZhong Nanshan, Zheng Zeguang

The First Affiliated Hospital of Guangzhou Medical University

zheng862080@139.com+86 189 2886 8242

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026