Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis

Completed

• Conditions: Chronic Bronchitis; 10038716

• Registration Number: NL-OMON55018
• Lead Sponsor: CSA MEDICAL, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1) Males and females >=40 to <80 years of age.
2) Subject is able to read, understand, and sign a written Informed Consent in
order to participate in the study.
3) Subject has a diagnosis of CB and COPD and has been symptomatic for a
minimum of two years. (Chronic Bronchitis 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).
4) Subject is classified as having moderate or severe (GOLD stage 2-3) airflow
obstruction defined by a post-bronchodilator of =>30% FEV1 to <80% predicted
with a baseline FEV1/FVC of <0.70.
5) Subject has a COPD assessment tool (CAT) score of >=10.
6) Subject is being treated according to current medically accepted treatment
guidelines without successful resolution of chronic bronchitis and agrees to
continue maintenance pulmonary/COPD medications (as defined per GOLD Standard
for medications) for the duration of the study (subject must be on a regime of
pulmonary medications for a minimum of 2 weeks prior to enrolment into the
study).
7) Smoking history of at least 10 pack years.
8) Non-smoking for a minimum of 2 months prior to consent and agrees to
continue not smoking for the duration of the study.
9) Subject is able to adhere to and undergo 4 bronchoscopic procedures (5 for
control subjects accepting cross over option), in the opinion of the
investigator or per hospital guidelines.
10) For women of childbearing potential: non-pregnant, non-lactating, and agree
to practice an adequate birth control method (abstinence, combination barrier
and spermicide, or hormonal) for the duration of the study.

Exclusion Criteria

1)Subject has had an acute pulmonary infection, exacerbation or pneumonia
requiring medical treatment (with antibiotics and/or steroids) within 6 weeks
of initially planned study bronchoscopy.
2) Diagnosis of asthma with an onset before 30 years of age.
3) Subject has Alpha-1 antitrypsin deficiency.
4) Subject has other origins of respiratory disease aside from chronic
bronchitis and COPD.
5) Subject is using e-cigarettes, vaping or taking any oral or inhaled
substances not prescribed by a physician.
6) Subject has untreatable or life-threatening arrhythmias, or history of
inability to adequately oxygenate during a bronchoscopy, or has acute
respiratory failure with hypercapnia.
7) Subject has bullous emphysema characterized as large bullae >30 millimetres
on HRCT; or subject has stenosis in the tracheobronchial system,
tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis.
8)Subject has clinically significant bronchiectasis
9)Subject has had a transplant procedure (any).
10) Subject has a known mucosal tear, has undergone prior lung surgery such as
pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery,
bronchial thermoplasty or cryotherapy.
11) Subject has had a prior lung device procedure, including emphysema stent(s)
implanted, lung coils, valves, lung denervation or other devices for emphysema.
12) Subject is unable to temporarily discontinue use of anticoagulant therapy:
warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal).
13) Subject has a serious medical condition, such as: uncontrolled coagulopathy
or bleeding disorder, 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, autoimmune disease or uncontrolled gastric reflux.
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 clinical investigational study within 6
weeks of enrolment.
16) Subject has known sensitivity to medication required to perform
bronchoscopy (such as lidocaine, atropine, and benzodiazepines).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Change in goblet cell density ( (cells per mm of basement membrane) in<br /><br>endobronchial cryobiopsies at 6-months between treatment and sham-control<br /><br>groups</p><br>