A Therapy for Improving Symptoms in Patients With Acute Exacerbations of COPD by Hydrogen-Oxygen Generator With Neburlizer.

NCT04000451 | Completed

• 1 other identifier: HM20180607
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose for this study is to determine safety and effectiveness of the oxyhydrogen generator with nebulizer through a therapy for improving symptoms in patients with acute exacerbations of copd.

Conditions

Copd Exacerbation Acute

Keywords

Copd Exacerbation Acute; oxygen; oxyhydrogen

Outcome Measures

Primary Outcomes (1)

• The Breathlessness, Cough, and Sputum Scale(BCSS score)

  The breathlessness, cough and sputum scale (BCSS) is a three-item questionnaire rating breathlessness, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms).the total total is 12. Variables to be measured or calculated are: from the Baseline to the seventh day.

  everyday from the baseline to the seventh day

Secondary Outcomes (9)

• COPD assessment test (CAT)

  baseline and the seventh day

• FEV1

  baseline and the seventh day

• FVC

  baseline and the seventh day

• FEV1/FVC

  baseline and the seventh day

• PaO2

  baseline and the seventh day

Study Arms (2)

oxyhydrogen

EXPERIMENTAL

conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ hydrogen/ oxygen inhaled

Device: oxyhydrogen; Drug: Conventional treatment

oxygen

EXPERIMENTAL

conventional treatment (bronchodilator (LABA,LAMA) with or without ICS)+ oxygen inhaled

Device: Oxygen; Drug: Conventional treatment

Interventions

oxyhydrogen DEVICE

Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days

oxyhydrogen

Oxygen DEVICE

oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days

oxygen

Conventional treatment DRUG

Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in seven days before the study

oxygen; oxyhydrogen

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meet the diagnostic criteria of chronic obstructive pulmonary disease (COPD)\[1\] : In the examination of pulmonary function, after inhalation of bronchodilator, the volume of forced air in one second accounted for 70% of forced vital capacity (FEV1 / FVC%) , fev180% ;
• meet the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)\[2\] : compared with the stable phase, the patient's condition has continued to deteriorate, more than the normal changes in the daytime, that is, patients with chronic obstructive pulmonary disease foundation for acute onset, need to adjust the routine medication. There are at least 2 of the following 3 items in the continuous deterioration of clinical symptoms: 1 aggravation of shortness of breath; 2 increase of Sputum Volume; 3 purulent sputum; or at least 1 of the above 3 symptoms, but one of the other 5 indicators should be added, 1 fever; 2 increased respiratory frequency and heart rate by 20% compared with the baseline; 3 aggravated cough; 4 Pharyngodynia and runny in the last 5 days; 5 increased wheezing;
• the age is over 40 years old and has the normal independent judgment ability patient, the male and the female are not limited;
• AECOPD patients requiring in-patient Care;
• patients with BCSS score ≥6 at the time of admission;
• patients who volunteer for the trial and sign an informed consent form.

You may not qualify if:

• screening period of intravenous or oral administration of more than 80 mg / day of methylprednisolone or equivalent dose of other hormones or serious need for continuous non-invasive ventilation patients;
• having a significant disease other than COPD, which, according to the researchers'judgement, would put the participants at risk for participating in the study or have an impact on the results of the study and the participants'ability to participate in the study;
• other respiratory diseases: subjects with other active pulmonary diseases, such as active tuberculosis, lung cancer, bronchiectasis disease (CT showed repeated acute exacerbations of bronchiectasis disease) , sarcoidosis, idiopathic interstitial pulmonary fibrosis (IPF) , primary pulmonary hypertension, uncontrolled Sleep apnea (i.e. , according to the researchers, the severity of the disease would influence the study) ;
• Lung Rehabilitation: Participants in the Lung Rehabilitation Program during the study period;
• a history of severe heart disease such as acute myocardial infarction, congestive heart failure (NYHA Class III and above) , Severe Arrhythmia and other acute heart disease;
• serious primary diseases of important organs and systems, such as acute stroke, hypertension above moderate after treatment, active gastric ulcer, diabetes Mellitus (serious complication) , malignant tumor, etc.
• confirmed and suspected cases of lung cancer;
• a history of one or more lobectomies;
• limited understanding and poor compliance;
• lack of or restricted legal capacity;
• those who have participated in clinical trials of other drugs or medical devices within 30 days prior to screening but have not reached the end point of the trial;
• pregnant, lactating women and women of childbearing age who do not agree to effective contraceptive measures during the study period;
• Persons with mental or physical disabilities;
• a suspected or confirmed history of alcohol or Drug Abuse;
• those who are known to be intolerant to inhalation therapy;

Sponsors & Collaborators

• Shanghai Asclepius Meditec Inc.: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• The First Hospital of Hebei Medical University: collaborator
• Fudan University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Tianjin Medical University General Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (3)

• Leidy NK, Schmier JK, Jones MK, Lloyd J, Rocchiccioli K. Evaluating symptoms in chronic obstructive pulmonary disease: validation of the Breathlessness, Cough and Sputum Scale. Respir Med. 2003 Jan;97 Suppl A:S59-70.

  PMID: 12564612 BACKGROUND

• Leidy NK, Rennard SI, Schmier J, Jones MK, Goldman M. The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretation. Chest. 2003 Dec;124(6):2182-91. doi: 10.1378/chest.124.6.2182.

  PMID: 14665499 BACKGROUND

• Zheng ZG, Sun WZ, Hu JY, Jie ZJ, Xu JF, Cao J, Song YL, Wang CH, Wang J, Zhao H, Guo ZL, Zhong NS. Hydrogen/oxygen therapy for the treatment of an acute exacerbation of chronic obstructive pulmonary disease: results of a multicenter, randomized, double-blind, parallel-group controlled trial. Respir Res. 2021 May 13;22(1):149. doi: 10.1186/s12931-021-01740-w.

  PMID: 33985501 DERIVED

MeSH Terms

Interventions

Oxygen Inhalation Therapy

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 27, 2019
• Study Start: January 7, 2019
• Primary Completion: June 1, 2019
• Study Completion: September 20, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)