Freezing lung lining again? small study tests repeat cryospray safety in COPD
NCT ID NCT07468617
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether it is safe to repeat a procedure called metered cryospray in people with COPD and chronic bronchitis who have already had it once. Only 10 participants will be enrolled. The main goal is to see if the treatment can be fully delivered and to track any serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metered cryospray (device)
- What this could lead to
- If safe, this could offer a repeatable procedure to ease chronic bronchitis symptoms in COPD patients.
- What could go wrong
- This is a very small safety study (10 people) with no control group. It only tests if repeat treatment is safe, not if it works. Risks include serious device- or procedure-related adverse events.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject has completed a previous MCS study, including both treatments (treatment day 1 and treatment day 2) 2. Males and females \<80 years of age 3. Subject is able to read, understand, and sign a written informed consent form in order to participate in the study 4. 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) 5. 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 6. Subject is being treated according to current medically accepted treatment guidelines for CB for minimum of 3 months prior to enrollment into the study. 7. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study 8. Subject is able to adhere to and undergo 2 bronchoscopic procedures per hospital guidelines Exclusion Criteria: 1. 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 2. Subject has other origins of respiratory disease aside from CB and COPD 3. Subject is using e-cigarettes, vaping or inhaled substances not prescribed by a physician 4. Subject has untreatable or life-threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure 5. 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 6. Subject has clinically significant bronchiectasis as determined by the investigator 7. Subject has had a solid organ transplant procedure 8. Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery 9. Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies 10. Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal) 11. Subject is unable to complete patient reported outcome questionnaires due to cognitive impairment, previous cerebral infarct e.g. stroke, TIA 12. 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 13. Subject is pregnant, nursing, or planning to get pregnant during study duration 14. 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 15. 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 16. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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