Chronic obstructive pulmonary disease
Conditions
Interventions
Sponsors
Shanghai Tenth people's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 30-80 years (inclusive) 2.Clinical diagnosis of mild to severe (GOLD score grade 1-3) chronic obstructive pulmonary disease complicated with chronic bronchitis; 3.No contraindications for bronchoscopy as evaluated by investigators 4.No acute exacerbation within 4 weeks before screening 5.Having given up smoking within 2 months before screening 6.Being unable to understand the objective of the study and voluntary to participate in this study, and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1.Having the respiratory disease that significantly affects the effect of the study treatment or other active respiratory disease: e.g., chronic cough caused by other reasons (e.g., cardiogenic), active tuberculosis, lung cancer, bronchiectasis, airway stenosis, sarcoidosis, pulmonary fibrosis, severe pulmonary hypertension (ultrasound measurement of pulmonary artery pressure=70mmHg), interstitial lung disease, cystic fibrosis, obliterative bronchiolitis, pulmonary bulla with the maximum diameter >3cm, or other active pulmonary disease 2.Having serious arrhythmia, acute respiratory failure, uncontrolled asthma, serious airway stenosis or other diseases that could not tolerate bronchoscopic intervention 3.Having serious cardiac, hepatic or renal dysfunction/impairment 4.Having cancer (except the cervical cancer in situ that has been cured for more than 5 years, squamous-cell carcinoma and basal-cell carcinoma of skin) 5.Having bacteremia, toxemia or other serious infectious diseases 6.Previous or ongoing participation in other drug or device clinical study within 4 weeks before screening 7.Having pulmonary infection within 6 weeks before screening (may be screened again after rehabilitation through treatment) 8.Having a history of hemorrhagic disease within 3 months before screening 9.Having myocardial infarction, angina pectoris or heart failure within 6 months before screening 10.Previous pneumonectomy, or plan for pulmonary operation, lung resection surgery or lung volume reduction surgery for mucosal tear during the study 11.Having undergone interventional treatment of pulmonary medical device previously, e.g., stent, spring coil, pulmonary valve implantation, bronchial thermal ablation (BT) 12.Having undergone lung transplantation previously, or plan or lung transplantation during the study 13.Known contraindication for anaesthesia, sedative drugs and anticoagulation 14.Known allergy to the component of this study product 15.Female subject who is pregnant, lactating or plans for pregnancy during the study 16.Ongoing use of electronic cigarette, smoking or any oral or inhalable substance unspecified by physician 17.Life expectancy < 12 months 18.Other conditions evaluated by investigators as unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SGRQ score response rate at Month 6 post the last therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate of operation;SGRQ score response rate at Month 1, 3 and 12 post the last therapy;CAT score improvement at Month 1, 3, 6 and 12 post the last therapy;Pulmonary function (FVC, FEV1, FEV1/FVC) at Month 1, 3, 6 and 12 post the last therapy;6-minute walking distance at Month 1, 3, 6 and 12 post the last therapy;Number of acute exacerbation at Month 1, 3, 6 and 12 post the last therapy;Volume of sputum score at Month 1, 3, 6 and 12 post the last therapy; | — |
Countries
China
Contacts
Public ContactChanghui Wang
Shanghai Tenth people's Hospital
Outcome results
None listed