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Trial record 1 of 1 for:    NCT03892694
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Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

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ClinicalTrials.gov Identifier: NCT03892694
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.

Brief Summary:
To evaluate the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS).

Condition or disease Intervention/treatment Phase
COPD Chronic Bronchitis Device: RejuvenAir System Other: Sham Not Applicable

Detailed Description:
To identify the molecular and cellular targets of MCS treatment and determine the mechanistic relationship to airways remodelling in patients with chronic bronchitis. Phenotype, characterise and correlate clinical, physiological, histological and molecular parameters in patients with chronic bronchitis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective, multi-centre, randomised, blinded, sham controlled trial with 1:1 randomisation. Sham-control arm subjects are eligible to receive treatment after the 6-month visit.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Sham controlled.
Primary Purpose: Treatment
Official Title: Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment
MCS
Device: RejuvenAir System
Bronchial metered cryospray using RejuvenAir® System.

Sham Comparator: Sham Control
Sham
Other: Sham
Sham control procedure




Primary Outcome Measures :
  1. Goblet cell density [ Time Frame: 6-months post treatment ]
    Change in goblet cell density in endobronchial cryobiopsies at 6-months between treatment and sham-control groups


Secondary Outcome Measures :
  1. Histopathological examination of endobronchial tissue to determine Inflammatory cell populations [ Time Frame: 6-months post treatment ]
    Proportion of inflammatory cells per mm of basement membrane for Neutrophil and Lymphocyte sequencing (RNA-seq)

  2. Histopathological examination of endobronchial brushings to determine epithelial cell populations [ Time Frame: 6-months post treatment ]
    Proportion of epithelial cells per mm of basement membrane for Ciliary and Goblet cells

  3. Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq) [ Time Frame: 6-months post treatment ]
    Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)

  4. Microvesicle quantification [ Time Frame: 6-months post treatment ]
    Microvesicle quantification

  5. Lobar volumes and gas trapping as determined by quantitative CT and parametric response mapping [ Time Frame: 6-months post treatment ]
    Lobar volumes and gas trapping as determined by quantitative CT and parametric response mapping

  6. Small airways function as assessed through specialist lung function techniques [ Time Frame: 6-months post treatment ]
    Small airways function as assessed through specialist lung function techniques

  7. Correlation between primary outcome and secondary outcomes 1-6 with clinical outcome parameters [ Time Frame: 6-months post treatment ]
    Correlation between primary outcome and secondary outcomes 1-6 with clinical outcome parameters including pulmonary function tests, patient reported outcome measures (CAT and SGRQ's) health care utilisation tests (number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events) and 6-minute walk tests.



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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each Subject must meet the following criteria to be enrolled in the study:

  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:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  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, rheoplasty 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892694


Contacts
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Contact: Heather Nigro 781-538-4793 hnigro@csamedical.com
Contact: Joyce Musacchio 781-538-4794 jmusacchio@csamedical.com

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Karin Klooster, PhD    0031-646-03226    k.klooster@umcg.nl   
Principal Investigator: Dirk-Jan Slebos, MD         
United Kingdom
The Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Christopher Orton, MD    02073518029    C.Orton@rbht.nhs.uk   
Principal Investigator: Pallav Shah, MD         
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
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Principal Investigator: Pallav Shah, MD The Royal Brompton Hospital
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Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT03892694    
Other Study ID Numbers: 022
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Acute Disease
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes