Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Control group:sham surgery
Treated group:Liquid Nitrogen Cryotherapy
Sponsors
Shanghai Tenth People’s Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 40 and 80 years old; 2. Diagnosed with chronic obstructive pulmonary disease (COPD) with chronic bronchitis for at least two years. 3. Categorized as having moderate to very severe (GOLD stages 2-4) airflow obstruction, characterized by post-bronchodilator FEV1 < 80%, and FEV1/FVC < 0.70 after bronchodilator use. 4. Experiencing two exacerbations or one hospitalization within the year prior to inclusion in the study; however, no acute exacerbations within the six weeks preceding enrollment. 5. Having quit smoking for at least one month prior to study inclusion and agreeing to continue abstaining from smoking during the study period; 6. Capable of using electronic devices to complete electronic diaries; 7. Able to understand the purpose of the trial, consenting to participate in this study and having signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of significant respiratory diseases that affect the trial treatment outcomes or other activities, such as chronic cough due to other than the target condition (e.g., cardiogenic), active pulmonary tuberculosis, lung cancer, bronchiectasis, airway stenosis, nodular disease, pulmonary fibrosis, severe pulmonary hypertension (echocardiography-measured pulmonary artery pressure =70 mmHg), interstitial lung disease, cystic fibrosis, bronchiolitis obliterans with a maximum diameter exceeding 3 cm, or other active pulmonary diseases. 2. Presence of severe arrhythmias, acute respiratory failure, uncontrolled asthma, or severe airway stenosis that would preclude tolerance to bronchoscopic intervention. 3. Presence of severe organ dysfunction or impairment in the heart, liver, kidney, or other organs. 4. Participants with cancer (with the exception of those who have been disease-free for over 5 years for primary cervical cancer, cutaneous squamous cell carcinoma, and basal cell carcinoma, etc.). 5. Presence of bacteremia, septicemia, or other severe infectious diseases. 6. Participants who have participated or are currently participating in other clinical studies involving drugs or devices within the 4 weeks prior to screening. 7. History of pulmonary infection within the 6 weeks prior to screening (may be re-screened after recovery from treatment). 8. History of bleeding disorders within the 3 months prior to screening. 9. History of myocardial infarction, angina, or heart failure within the 6 months prior to screening. 10. History of lung resection or planned lung surgery, including resection or volume reduction procedures due to reasons such as mucosal tear, within the trial period. 11. History of pulmonary medical device interventions, such as stents, coils, lung valve implants, bronchial thermoplasty (BT), etc. 12. History of lung transplantation or plans for lung transplantation during the trial period. 13. Known contraindications to anesthetics, sedatives, and anticoagulants. 14. Known allergies to any components of the trial product. 15. Pregnant, breastfeeding, or planning to become pregnant during the trial period. 16. Use of electronic cigarettes, smoking, or intake of any oral or inhaled substances not prescribed by the physician. 17. Participants with an expected lifespan less than 12 months. 18. Any other conditions deemed by the investigator as unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of the St. George's Respiratory Questionnaire (SGRQ) score at six months after the last treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgical success rate;Response rate of the St. George's Respiratory Questionnaire (SGRQ) scores at 1, 3, and 12 months after the last treatment.;Improvement in Chronic Obstructive Pulmonary Disease Assessment Tool (CAT) scores at 1, 3, 6, and 12 months post-final treatment.;Pulmonary function (forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC ratio) at 1, 3, 6, and 12 months after the last treatment.;6-minute walk distance at 1, 3, 6, and 12 months after the last treatment.;Number of acute exacerbations at 1, 3, 6, and 12 months following the final treatment;Sputum Score at 1, 3, 6, and 12 months post-final treatment; | — |
Countries
China
Contacts
Public ContactSong Xiaolian
Shanghai Tenth People’s Hospital
Outcome results
None listed