Chronic Bronchitis, COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis, CB, Metered Cryospray, Cryospray, RejuvenAir System
Brief summary
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.
Detailed description
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. This is an open-label study. Eligible subjects will have previously completed the SPRAYCB study (NCT03893370). Subjects will receive 2 sessions of bronchial metered cryospray using RejuvenAir® System. Each session will be separated by approximately 30-45 days. Subjects will be followed at 3-month and at 6-months post second procedure.
Interventions
DEVICEMetered cryospray (MCS)
Bronchial metered cryospray (MCS)
Sponsors
CSA Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible subjects will receive Metered Cryospray (MCS) treatment
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completed MCS treatment applications | Treatment 1 and Treatment 2 | Completed MCS treatment applications at Treatment 1 and Treatment 2 defined as \> or = to 80% of fully delivered MCS applications at each procedure. \[Percent of full vs. total applications at each procedure\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of serious device-related adverse events | Total events within 30 days of Treatment 1 and Treatment 2 | The number of serious device-related adverse events \[Total events within 30 days of Treatment 1 and Treatment 2 \] |
| The number of serious procedure-related adverse events | Total events within 30 days of Treatment 1 and Treatment 2 | The number of serious procedure-related adverse events \[Total events within 30 days of Treatment 1 and Treatment 2 \] |
| Patient reported outcome measures using SGRQ Total Score | Time Frame: 6-months post treatment relative to baseline | Patient reported outcome measures using SGRQ Total Score, \[Time Frame: 6-months post treatment relative to baseline \]. SGRQ scores are continuous values ranging from 0 (no symptoms) to 100 (severe symptoms). A reduction in score indicates an improvement. |
| Patient reported outcome measures using CAT Total Score | Time Frame: 6-months post treatment relative to baseline | Patient reported outcome measures using CAT Total Score, \[Time Frame: 6-months post treatment relative to baseline \]. It provides a standardized score (0-40). A reduction in score indicates an improvement. |
Outcome results
None listed