Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02850185
• Date of registration: 22/07/2016
• Prospective Registration: No
• Primary sponsor: Shanghai Asclepius Meditec Inc.
• Public title: Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer
• Scientific title: Adjuvant Therapy for Severe COPD Patients in the Stable Phase by an Oxyhydrogen Generator With Nebulizer: A Multi-centric, Randomized, Parallel-control and Double-blinded Clinic Study
• Date of first enrolment: July 15, 2016
• Target sample size: 170
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02850185
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Zhong N Shan, academician
• Affiliation: First Affiliated Hospital of Guangzhou Medical University

• Name: Zheng Z Guang, doctor

• Name: Zheng Z Guang, doctor

Key inclusion & exclusion criteria

Inclusion Criteria:

1. It conforms to the diagnostic criteria of chronic obstructive pulmonary diseases
(COPD): (PFT)The percentage of forced expiratory volume in forced vital capacity in
one second after inhaling vasodilator (FEV1 / FVC% < 70%);

2. Classification of COPD severity by pulmonary function: The criterion for this study is
Severe: FEV1/FVC<0.70, and FEV1< 50% expected value after pulmonary function was
examined by taking bronchodilator.

3. More than 40 years old and have normal ability to judge independently; men and women
are not limited;

4. Living in the vicinity of the test centre in the past six months; -

Exclusion Criteria:

- 1) Those who have acute exacerbation in the past 4 weeks; 2) Lung disease history:
Excluding the history of other lung diseases except combined COPD, such as combined
pulmonary tuberculosis and diffuse pan-capillary bronchiolitis, pneumonia,
pneumothorax, pleural effusion, pulmonary embolism, etc.

3) Those who suffer infectious diseases such as hepatitis A, hepatitis B, AIDS and
tuberculosis or connective tissue diseases in the active period; 4) Those who suffer
high fever, as well as various local or systemic infections (including respiratory,
urinary and reproductive system, digestive system, sepsis, etc.), severe infection,
especially lung infection found by CT examination; 5) Those who have limited ability
to understand and poor compliance; do not have the legal capacity or limited legal
capacity; participated in other clinical trials in the first 3 months when they were
included in the groups; mental or physical disability; 6) Those who were difficult to
make an exact evaluation on safety and effectiveness of products; 7) The women in
pregnancy and lactation, as well as the women at childbearing age who don't agree to
take effective contraceptive measures during the study period; 8) Those who have
abnormal heart function and thrombophlebitis; 9) Those who are known and can't stand
the oxygen and hydrogen inhalation; 10) Those who are suffered from primary diseases
in important visceral organs and systems, such as stroke, severe hypertension, gastric
ulcer, uncontrolled diabetes, malignant tumor, liver and kidney failure, and severe
heart disease history (acute myocardial infarction, congestive heart failure and other
heart diseases in the acute phase); 11) Cancer in progressive stage as well as
undetermined masses found in the treatment; 12) Those who have one or more lobectomy
history; 13) Those who are suspected to have or really have alcohol and drug abuse
history; 14) Those whose AST and ALT=120U/L, Ccr=50ml/min; who have shock or unstable
hemodynamics; 15) Those who are considered not to participate in clinical trials by
the investigators.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

COPD

Intervention(s)

Device: Oxygen

Drug: Conventional treatment

Device: oxyhydrogen

Primary Outcome(s)

Change from Baseline in dyspnea index score (mMRC score) at 3 months [Time Frame: baseline and 3 months]

Secondary Outcome(s)

Change from Baseline in First second forcibly expiration quantity(FEV1) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Forcibly vital capacity(FVC) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Serum tumor necrosis factor-a(TNF-a) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Residual volume(RV) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Serum interleukin-6(IL-6) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in carbon dioxide arterial tension (PaCO2) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Serum interleukin-8( IL - 8) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Pulmonary artery pressure measured by heart color Doppler ultrasound at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in mean maximum expiratory flow(MMEF) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Six minute walk distance at 3 months [Time Frame: baseline and 3 months]

number of participants with adverse events [Time Frame: up to 3 months]

Change from Baseline in Arterial oxygen tension (PaO2) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Serum malondialdehyde (MDA) at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in Serum 8-isoprostane at 3 months [Time Frame: baseline and 3 months]

Change from Baseline in St George's respiratory questionnaire (SGRQ score) at 3 months [Time Frame: baseline and 3 months]

Secondary ID(s)

ZZheng

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The First Affiliated Hospital of Guangzhou Medical University

Second Affiliated Hospital of Guangzhou Medical University

Tianjin Medical University General Hospital

West China Hospital

The Second Hospital of Hebei Medical University