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

NCT03892694 | Active Not Recruiting DMC

• 1 other identifier: 022
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

COPD; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• Goblet cell density

  Difference in change relative to baseline in goblet cell density per mm of basement membrane in endobronchial cryobiopsies at 6-months between treatment and sham-control groups

  6-months post treatment

Secondary Outcomes (7)

• Histopathological examination of endobronchial cryobiopsies to determine Inflammatory cells and subtype density per mm of basement membrane

  6-months post treatment

• Histopathological examination of endobronchial cryobiopsies to determine epithelial cell density and area (including respiratory epithelial, goblet and basal cells) per mm of basement membrane

  6-months post treatment

• Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)

  6-months post treatment

• Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO

  6-months post treatment

• Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires

  6-months post treatment

Other Outcomes (4)

• Microvesicle quantification

  6-months post treatment

• Lobar volumes and gas trapping as determined by quantitative CT and parametric response mapping

  6-months post treatment

• Small airways function as assessed by Impulse Oscillometry (IOS)

  6-months post treatment

Study Arms (2)

Treatment

ACTIVE COMPARATOR

MCS

Device: RejuvenAir System

Sham Control

SHAM COMPARATOR

Sham

Other: Sham

Interventions

RejuvenAir System DEVICE

Bronchial metered cryospray using RejuvenAir® System.

Treatment

Sham OTHER

Sham control procedure

Sham Control

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each Subject must meet the following criteria to be enrolled in the study:
• Males and females ≥40 to \<80 years of age.
• Subject is able to read, understand, and sign a written Informed Consent in order to participate in the study.
• 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).
• 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.
• Subject has a COPD assessment tool (CAT) score of ≥10.
• 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).
• Smoking history of at least 10 pack years.
• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study.
• 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.
• 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.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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.
• 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 is using e-cigarettes, vaping or taking any oral or inhaled substances not prescribed by a physician.
• Subject has untreatable or life-threatening arrhythmias, or history of inability to adequately oxygenate during a bronchoscopy, or has acute respiratory failure with hypercapnia.
• 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.
• Subject has clinically significant bronchiectasis
• Subject has had a transplant procedure (any).
• 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.
• Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation or other devices for emphysema.
• Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal).
• 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.
• 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.

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

Location

The Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Pallav Shah, MD

  The Royal Brompton Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Sham controlled.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: February 14, 2020
• Primary Completion: July 11, 2022
• Study Completion: June 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

NL (1); GB (1)