Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Control group:Control valve rehabilitation training
Experimental group:Zheng's multifunctional respiratory valve
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Give their signed written informed consent to participate; 2. Aged 40 to 80 years; 3. Female participant should be non-child bearing potential (i.e., physiologically incapable of becoming pregnant,including any female who is 2 years post-menopausal); or no pregnancy plan. 4. COPD Diagnosis: Subjects with an established clinical history of COPD as defined by 2013 Chinese medical association respiratory branch, it's characterized should be airflow limitation that is not fully reversible. Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking; 5. Smoking history: current or former smokers with a history of at least one years of cigarette smoking. 6. Severity of Disease: Subjects with an established clinical history of COPD and severity defined as lung function results at Visit 1 or in the first 12 months of the visit, FEV 1 /FVC ratio of <0.70 and FEV 1 must be <80% predicted normal value. Must provide a reliable report of lung ventilation function in the previous 12 months; 7. Subjects are willing and able to complete rehabilitation training according to the programme; 8. Subject can complete the related inspection project; 9. Chest X-ray or computed tomography (CT) scan of the chest/lungs within 12months prior to Visit 1 must be acceptable to the Investigator. Subjects who have a chest X-ray (or CT scan) that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included; 10. Compliance: Subjects must be willing to remain at the hospital as required per protocol to complete all visit assessments.
Exclusion criteria
Exclusion criteria: 1. Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subjects ability to participate in the study; 2. Pregnancy: Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception; 3. Respiratory conditions: 1) Asthma: Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma; 2) Alpha-1 Antitrypsin Deficiency: Subjects who have alpha-1 antitrypsin deficiency as the cause of COPD; 3) Other Respiratory Disorders: Subjects who have other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis (High Resolution CT evidence of bronchiectasis that cause repeated acute exacerbations), sarcoidosis,idiopathic interstitial pulmonary fibrosis (IPF), primary pulmonary hypertension,or uncontrolled sleep apnea (i.e., in the opinion of the Investigator severity of the disorder would impact the conduct of the study). Combined with pneumothorax, pleural effusion, pulmonary embolism, bronchial asthma, tumor, unexplained causes of fever, large pulmonary blisters, etc.; 4) Lung Volume Reduction: Subjects who have undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants) within 1 year of Visit 1; 5) Hospitalization: Subjects who have been hospitalized due to poorly controlled COPD within one months prior to Visit 1 (Screening) or during the Screening Period(Visit 1 to Visit2); 6) Poorly Controlled COPD: Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 4 weeks prior to Visit 1 (Screening); 7) Lower Respiratory Tract Infection: Subjects who had lower respiratory tract infections that required antibiotics within 6 weeks prior to Visit 1 (Screening); 8) Upper respiratory tract infection (URTI) recovered less than 7 days before screening; 9) Risk factors for pneumonia: immunosuppression (HIV), severe neurological disease that affects upper respiratory control, or other risk factors that researchers believe will lead to significant pneumonia risk; 10) Pneumonia was not clinical recovery in 14 days prior to visit 1; 11) Pulmonary Rehabilitation: Subjects who have participated in the acute phase of a pulmonary rehabilitation program or other program within 4 weeks prior to Visit 1 (Screening); 12) The drug therapy regimen for COPD and oral bronchiectasis had not been modified for at least 4 weeks; 4. Serious primary diseases such as heart, liver, kidney, hematopoietic system, etc.; 5. Patients with Lower back, damaged chest or abdomen,postoperative; 6. Mental disorders, cognitive disordered; 7. nonadherence:Do not follow the study step subjects, including not to complete the log; 8. Questionable Validity of Consent: Subjects with a history of psychiatric disease,intellectual deficiency, poor motivation, substance abuse (including drug and alcohol), or other conditions that will limit the validity of informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| he first moderate or severe acute exacerbation of COPD during the whole December;6 minute walking test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak expiratory flow;CCQ questionnaire;SGRQ questionnaire;CAT questionnaire;MMRC dyspnea score;Cough expectoration score; | — |
Contacts
Public ContactZheng Zeguang
Guangzhou University of Medical The First Affiliated Hospital of Guangzhou University of Medical
Outcome results
None listed