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Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892694
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : January 3, 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
Estimated Study Start Date : February 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 ]
    Goblet cell density



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females ≥40 to <80 years of age.
  • 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).
  • 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.
  • Smoking history of at least 10 pack years.
  • 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:

  • Diagnosis of asthma with an onset before 30 years of age.
  • Subject has Alpha-1 antitrypsin deficiency.
  • Subject has other origins of respiratory disease aside from chronic bronchitis and COPD.
  • 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.

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: Joyce Musacchio 781-538-4794 jmusacchio@csamedical.com

Sponsors and Collaborators
CSA Medical, Inc.

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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: January 3, 2020
Last Verified: January 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