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An exploratory study on spray cryotherapy under bronchoscope

Safety and efficacy of bronchoscopy spray cryotherapy in the treatment of chronic obstructive pulmonary diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036346
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

Experimental group:Spray cryotherapy
Control group:None

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) 40-80 years old; (2) Chronic obstructive pulmonary disease (COPD) has been diagnosed for at least two years. (3) Classified as having moderate or severe (GOLD 2/3) airflow obstruction, with 30% =FEV1& LT by bronchodilator;80%, FEV1 / FVC<=0.70; (4) The subject's benchmark SGRQ is greater than 50; (5) In the year prior to study inclusion, the subjects had two moderate aggravations or one severe exacerbation;But there is no acute exacerbation at present or in the last 6 weeks. (6) Treatment in accordance with current medically recognized guidelines for THE treatment of COPD for at least 3 months prior to inclusion in the study; (7) have quit smoking for at least 2 months prior to inclusion in the study, and agree to remain non-smoking during the study period; (8) The patient can record or state the changes of his/her condition completely; (9) The subject can understand the purpose of the study, agrees to participate in the study and signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) Antitrypsin deficiency; (2) Other respiratory diseases associated with or clinically significant to the study, such as active pulmonary tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary interstitial disease, cystic fibrosis, bronchiolitis obliterans, or other active pulmonary diseases; (3) current or recent 4 weeks of pneumonia and/or moderate or severe acute exacerbation of copd; (4) the subject has an incurable or life-threatening arrhythmia, is unable to oxygenate during bronchoscopy, or suffers from acute respiratory failure with hypercapnia; (5) Prior pulmonary resection or lung volume reduction within 12 months prior to screening; (6) Subjects are using e-cigarettes, smoking cigarettes or taking any oral or inhaled substances not prescribed by the physician; (7) There are contraindications for anesthetic and sedative drugs; (8) Anticoagulant contraindications or a history of hemorrhagic disease within 6 months; (9) persons with severe organ dysfunction; (10) patients with systemic infection; (11) Women who are pregnant, breast-feeding or preparing to become pregnant; (12) Persons with other serious diseases and a life expectancy of less than 6 months; (13) Have participated in or are participating in other drugs or devices and other clinical researchers within 3 months before enrollment; (14) Other conditions assessed by the researcher not suitable for inclusion in this study, such as inappropriate anatomical structure, mental disorders or psychological disorders.

Design outcomes

Primary

MeasureTime frame
ERS;lung function;Number of acute episodes;

Countries

China

Contacts

Public ContactChanghui Wang

Shanghai Tenth People's Hospital

18717774084@163.com+86 18917683378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026