Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

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Conditions studied: COPD (Chronic Obstructive Pulmonary Disease), Chronic Bronchitis

In brief

This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS.

Key facts

Study ID: NCT07468617
Run by: CSA Medical, Inc.
People needed: 10
Starts: 2026-05-01
Expected to finish: 2027-05-01
Last updated by the study team: 2026-03-18

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has completed a previous MCS study, including both treatments (treatment day 1 and treatment day 2)
Males and females <80 years of age
Subject is able to read, understand, and sign a written informed consent form in order to participate in the study
Subject has a diagnosis of chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB) for a minimum of two years. (CB is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded)
Subject is classified as having a moderate or severe (GOLD 2/3) airflow obstruction defined by a post-bronchodilator of >30% FEV1 to <80% predicted with a baseline FEV1/FVC of <0.70
Subject is being treated according to current medically accepted treatment guidelines for CB for minimum of 3 months prior to enrollment into the study.
Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study
Subject is able to adhere to and undergo 2 bronchoscopic procedures per hospital guidelines

You may not qualify if…

Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy
Subject has other origins of respiratory disease aside from CB and COPD
Subject is using e-cigarettes, vaping or inhaled substances not prescribed by a physician
Subject has untreatable or life-threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
Subject has bullous emphysema characterized as large bullae >30 millimeters on High Resolution Computed Tomography (HRCT); or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis
Subject has clinically significant bronchiectasis as determined by the investigator
Subject has had a solid organ transplant procedure
Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies
Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
Subject is unable to complete patient reported outcome questionnaires due to cognitive impairment, previous cerebral infarct e.g. stroke, TIA
Subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or uncontrolled gastric reflux
Subject is pregnant, nursing, or planning to get pregnant during study duration
Subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study
Subject is or has been in another treatment study within 6 weeks of enrollment and agrees to not participate in any other treatment studies for the duration of study participation
Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)

Full record on ClinicalTrials.gov

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