Chronic BronchitisSPRAY-CBNCT03893370
RejuvenAir® System Trial for COPD With Chronic Bronchitis
A study testing RejuvenAir System in people with Chronic Bronchitis, run by CSA Medical, Inc. at 27 sites in 2 countries.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Bronchitis
- What is being tested?
- RejuvenAir System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 9 Jul 2020to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 chronic bronchitis (CB) and/or chronic obstructive pulmonary disease (COPD) 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 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
- Subject has a Baseline SGRQ of ≥50
- Subject demonstrates daily cough and significant mucus.
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- Subject is being treated according to current medically accepted treatment guidelines for chronic bronchitis for minimum of 3 months prior to enrollment into the study. Subject agrees to continue maintenance pulmonary/COPD medications (GOLD standard medications recommended) for the duration of the study
- 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 2 bronchoscopic procedures (cross over subjects may undergo two additional bronchoscopic procedures, if they agree to treatment), per hospital guidelines
- Subject demonstrates ability and willingness to use a daily eDiary
Who cannot join
- 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
- Current diagnosis of Asthma
- Subject has Alpha-1 antitrypsin deficiency as defined by blood level <59 mg/dL
- Subject has other origins of respiratory disease aside from chronic bronchitis and COPD
- Subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed by a physician
- Subject has untreatable or life threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
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- Subject has bullous emphysema characterized as large bullae >30 millimeters 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 solid transplant procedure
- Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
- Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies
- 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 or uncontrolled gastric reflux
- Subject is pregnant, nursing, or planning to get pregnant during study duration
- 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
- 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
- Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States26 sites
Clinical Research Associates of Central PA
Altoona, Pennsylvania, 16601
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins Universtiy
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cooper Health System
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
University Of Cincinnati
Cincinnati, Ohio, 45267
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Prisma Health - Midlands
Columbia, South Carolina, 29203
The Ohio State Universisty
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27705
St. David's Georgetown Hospital
Georgetown, Texas, 78626
Spectrum Health
Grand Rapids, Michigan, 49503
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
El Camino Hospital
Mountain View, California, 94040
Temple University - Of the Commonwealth System of Higher Education
Philadelphia, Pennsylvania, 19140
University of California, Davis Medical Center
Sacramento, California, 95817
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Honor Health
Scottsdale, Arizona, 08258
Louisiana State University Medical Center
Shreveport, Louisiana, 71103
About this study
Official title: A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
Read the detailed description
The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. Cryotherapy with the RejuvenAir® System is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. This reversal of inflamed epithelium may also lessen systemic inflammation.
- Conditions
- Chronic Bronchitis
- Being tested
- RejuvenAir System, Sham Control Procedure
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RejuvenAir SystemDevice
RejuvenAir Metered CryoSpray
Sham Control ProcedureDevice
Sham Control Procedure
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | RJA MCS Receives: Device: RejuvenAir System |
| Sham Control | Sham comparator | Sham Receives: Device: Sham Control Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. George's Respiratory Questionnaire
Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months
Measured: 12 months
Secondary outcomes (5)
Subjects experiencing serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure
Number of subjects experiencing one or more serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure by the investigator within 30 days after either the first or second study procedure.
Measured: Within 30 days after either the first or second study procedure
Reduction of cough
Reduction of cough from Baseline through 12 months
Measured: Baseline through 12 months
Reduction of sputum
Reduction of sputum from Baseline through 12 months
Measured: Baseline through 12 months
Acute Exacerbation Rate (AECOPD)
Acute Exacerbation rate (AECOPD, all severities) over 12 months
Measured: 12 months
COPD assessment test (CAT) score
COPD assessment test (CAT) from Baseline through 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start9 Jul 2020
- Primary completionMay 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, sham-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Criner, MD, Principal investigator, Temple University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893370
- Sponsor's protocol ID
- 016
- Acronym
- SPRAY-CB
- Status last verified
- May 2024
- First submitted
- 26 Mar 2019
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT03893370
- Acronym / sponsor ID
- SPRAY-CB / 016
- Conditions
- Chronic Bronchitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- CSA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
Detailed description
The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. Cryotherapy with the RejuvenAir® System is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. This reversal of inflamed epithelium may also lessen systemic inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, sham-controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: RejuvenAir SystemRJA MCS |
| Sham Control | Sham comparator | Device: Sham Control ProcedureSham |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 chronic bronchitis (CB) and/or chronic obstructive pulmonary disease (COPD) 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 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
- Subject has a Baseline SGRQ of ≥50
Key exclusion criteria (17 listed)
- 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
- Current diagnosis of Asthma
- Subject has Alpha-1 antitrypsin deficiency as defined by blood level <59 mg/dL
- Subject has other origins of respiratory disease aside from chronic bronchitis and COPD
- Subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed by a physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RejuvenAir SystemRejuvenAir Metered CryoSpray | Device | Treatment |
| Sham Control ProcedureSham Control Procedure | Device | Sham Control |
Primary outcome
St. George's Respiratory Questionnaire
Time frame: 12 months
Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months
5 secondary outcomes
Subjects experiencing serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure
Time frame: Within 30 days after either the first or second study procedure
Reduction of cough
Time frame: Baseline through 12 months
Reduction of sputum
Time frame: Baseline through 12 months
Acute Exacerbation Rate (AECOPD)
Time frame: 12 months
COPD assessment test (CAT) score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Criner, MD principal investigator
Temple University Health System
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RejuvenAir System in people with Chronic Bronchitis, run by CSA Medical, Inc. at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St. George's Respiratory Questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.