Bronchitis, ChronicFeasibilityNCT02483637
Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients
A study testing RejuvenAir in people with Bronchitis, Chronic and Cryotherapy Effect, run by CSA Medical, Inc. at 3 sites in 3 countries.
Trial summary
This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Bronchitis, Chronic, Cryotherapy Effect
- What is being tested?
- RejuvenAir
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2016to 20 May 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥40 to ≤75 years of age.
- Subject is able to read, understand, and sign a written Informed Consent in order to participate in the study.
- Subject agrees to continue maintenance pulmonary/COPD medications for the duration of the study.
- Diagnosis of chronic bronchitis (CB) and 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.)
- Pre-procedure post bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within 3 months of enrollment.
- Smoking history of at least 10 pack years.
- Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study.
- Subject is able to adhere to and undergo 3 (4 if in Phase A) bronchoscope procedures that includes lung biopsies and multiple MCS treatments in the opinion of the investigator
Who cannot join
- Subject has had an acute pulmonary infection or pneumonia within prior 6 weeks of study bronchoscopy.
- Subject has had a CB and/or COPD exacerbation (requiring steroids and/or antibiotics) within 6 weeks prior to study bronchoscopy, as defined by their treating physician
- Subject has clinically significant bronchiectasis or other respiratory disease other than chronic bronchitis and COPD.
- Diagnosis of asthma with an onset before 30 years of age
- Subject has bullous emphysema characterized as large bullae >30 millimeters on CT.
- Subject has had a transplant.
Show all 20Show fewer
- Subject has the inability to walk >140 meters
- Subject has PaC02 >8kPa, or a PaO2<7kPa at room air.
- Subject has a RVSP >45mmHg or a LVEF<45% on 2D-cardiac echo.
- Subject has undergone lung surgery: pneumonectomy, lobectomy, bullectomy, lung volume reduction surgery
- 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, clopidogrel (or equal)
- Subject is on >10 mg of prednisolone/day.
- Subject has a serious medical condition, such as: 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, hypertension, autoimmune disease or uncontrolled gastric reflux
- Subject is pregnant, nursing, or planning to get pregnant during study duration.
- Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
- Subject is or has been in another clinical investigational study within 6 weeks of baseline.
- Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
- Subject has been in another clinical investigational study within 6 weeks of baseline.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Chelsea and Westminster Hosptial/Royal Brompton Hosptial
London, SW10 9NH
About this study
Official title: A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients
This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.
Read the detailed description
Prospective, open label, single arm study with sequential accrual of subjects with known chronic bronchitis. There are two phases to this study. Phase A will enroll up to 12 subjects and will treat a single lobe to assess safety, feasibility and histology/immunology. After review of the data by the Data Safety Monitoring Board, Phase B of the study would begin. In Phase B of the study, Phase A subjects would have their remaining two lobes treated. In addition up to 24 subjects will be enrolled and will have all upper and lower lobes treated to assess safety, feasibility and immunology.
- Conditions
- Bronchitis, Chronic, Cryotherapy Effect
- Being tested
- RejuvenAir
- Keywords
- spray cryotherapy, cryotherapy, chronic bronchitis, airflow restrictions
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RejuvenAirDevice
Device: RejuvenAir
| Study group | Role | What they receive |
|---|---|---|
| RejuvenAir | Experimental | RejuvenAir treatment of the right lower lobe and right main stem bronchus. Each MCS will be tailored to the bronchial area undergoing treatment and the amount of liquid nitrogen delivered will vary depending on the airway diameter. Receives: Device: RejuvenAir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse and Serious Adverse Events
Number of subjects with treatment emergent adverse events. Observed rates and two-sided 95% exact confidence interval will be calculated for AE rates and SAE rates overall and for organ class.
Measured: Change from Baseline to 3-Months Following Completion of Treatments
Ability to Complete all 3 MCS Treatments
Number of subjects completing all 3 treatments.
Measured: Change from Baseline to 3-Months Following Completion of Treatments
Patient Reported Outcome Instrument: St. George's Respiratory Questionnaire (SGRQ)
Scale is 0-100; a higher score is worse
Measured: Change from Baseline to 3-Months Following Completion of Treatments
Secondary outcomes (6)
Spirometry Testing
FEV1, FEV1/FVC, VC, FIV1
Measured: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
6 Minute Walk Test
Number of meters walked in six minutes
Measured: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Leicester Cough Questionnaire (LCQ)
The total score range is 19-133; a higher score is better.
Measured: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
COPD Assessment Test (CAT)
The total score range is 0-40; a higher score is worse
Measured: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Visual Analog Scale (VAS)
The total score range is 0-100; a higher score is worse
Measured: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Modified Medical Research Council (mMRC)
The total score range is 0-4; a higher score is worse
Measured: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completionMay 2019
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bronchitis, ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- RejuvenAir
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heather Nigro, Study director, CSA Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483637
- Sponsor's protocol ID
- 012
- Acronym
- Feasibility
- Status last verified
- Feb 2023
- First submitted
- 25 Jun 2015
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Thompson AB, Daughton D, Robbins RA, Ghafouri MA, Oehlerking M, Rennard SI. Intraluminal airway inflammation in chronic bronchitis. Characterization and correlation with clinical parameters. Am Rev Respir Dis. 1989 Dec;140(6):1527-37. doi: 10.1164/ajrccm/140.6.1527.
PubMed 2604284Innes AL, Woodruff PG, Ferrando RE, Donnelly S, Dolganov GM, Lazarus SC, Fahy JV. Epithelial mucin stores are increased in the large airways of smokers with airflow obstruction. Chest. 2006 Oct;130(4):1102-8. doi: 10.1378/chest.130.4.1102.
PubMed 17035444Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. Int J Chron Obstruct Pulmon Dis. 2014 Jan 24;9:139-50. doi: 10.2147/COPD.S38938. eCollection 2014.
PubMed 24493923Godwin BL, Coad JE, "Healing responses following cryothermic and hyperthermic tissue ablation. " SPIE Proceedings 2009: Volume 7181, p1-9
Sciurba FC, Ernst A, Herth FJ, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, McLennan G; VENT Study Research Group. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010 Sep 23;363(13):1233-44. doi: 10.1056/NEJMoa0900928.
PubMed 20860505Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.
PubMed 24429129Gibson PG. Cough is an airway itch? Am J Respir Crit Care Med. 2004 Jan 1;169(1):1-2. doi: 10.1164/rccm.2310009. No abstract available.
PubMed 14695099Jeffery P, Holgate S, Wenzel S; Endobronchial Biopsy Workshop. Methods for the assessment of endobronchial biopsies in clinical research: application to studies of pathogenesis and the effects of treatment. Am J Respir Crit Care Med. 2003 Sep 15;168(6 Pt 2):S1-17. doi: 10.1164/rccm.200202-150WS. No abstract available.
PubMed 14555461Pulmonary Physiology, Levitzky M. 7th ed. 2007, The McGraw-Hill Companies
Smith BM, Hoffman EA, Rabinowitz D, Bleecker E, Christenson S, Couper D, Donohue KM, Han MK, Hansel NN, Kanner RE, Kleerup E, Rennard S, Barr RG. Comparison of spatially matched airways reveals thinner airway walls in COPD. The Multi-Ethnic Study of Atherosclerosis (MESA) COPD Study and the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 Nov;69(11):987-96. doi: 10.1136/thoraxjnl-2014-205160. Epub 2014 Jun 13.
PubMed 24928812Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
PubMed 33590989
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Safety and Feasibility Study of the RejuvenAir™ System Metered Cryospray Therapy for Chronic Bronchitis Patients
- ClinicalTrials.gov ID
- NCT02483637
- Acronym / sponsor ID
- Feasibility / 012
- Conditions
- Bronchitis, Chronic, Cryotherapy Effect
- Keywords
- spray cryotherapy, cryotherapy, chronic bronchitis, airflow restrictions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CSA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2019 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 29 Jun 2015 (estimated)
- 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.
This study evaluates the safety of RejuvenAir Cryospray therapy to treat symptomatic chronic bronchitis patients with airflow restrictions.
Detailed description
Prospective, open label, single arm study with sequential accrual of subjects with known chronic bronchitis. There are two phases to this study. Phase A will enroll up to 12 subjects and will treat a single lobe to assess safety, feasibility and histology/immunology. After review of the data by the Data Safety Monitoring Board, Phase B of the study would begin. In Phase B of the study, Phase A subjects would have their remaining two lobes treated. In addition up to 24 subjects will be enrolled and will have all upper and lower lobes treated to assess safety, feasibility and immunology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RejuvenAir
| Arm | Type | Receives |
|---|---|---|
| RejuvenAir | Experimental | Device: RejuvenAirRejuvenAir treatment of the right lower lobe and right main stem bronchus. Each MCS will be tailored to the bronchial area undergoing treatment and the amount of liquid nitrogen delivered will vary depending on the airway diameter. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ≥40 to ≤75 years of age.
- Subject is able to read, understand, and sign a written Informed Consent in order to participate in the study.
- Subject agrees to continue maintenance pulmonary/COPD medications for the duration of the study.
- Diagnosis of chronic bronchitis (CB) and 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.)
- Pre-procedure post bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within 3 months of enrollment.
Key exclusion criteria (20 listed)
- Subject has had an acute pulmonary infection or pneumonia within prior 6 weeks of study bronchoscopy.
- Subject has had a CB and/or COPD exacerbation (requiring steroids and/or antibiotics) within 6 weeks prior to study bronchoscopy, as defined by their treating physician
- Subject has clinically significant bronchiectasis or other respiratory disease other than chronic bronchitis and COPD.
- Diagnosis of asthma with an onset before 30 years of age
- Subject has bullous emphysema characterized as large bullae >30 millimeters on CT.
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 |
|---|---|---|
| RejuvenAirDevice: RejuvenAir | Device | RejuvenAir |
Primary outcome
Adverse and Serious Adverse Events
Time frame: Change from Baseline to 3-Months Following Completion of Treatments
Number of subjects with treatment emergent adverse events. Observed rates and two-sided 95% exact confidence interval will be calculated for AE rates and SAE rates overall and for organ class.
Ability to Complete all 3 MCS Treatments
Time frame: Change from Baseline to 3-Months Following Completion of Treatments
Number of subjects completing all 3 treatments.
Patient Reported Outcome Instrument: St. George's Respiratory Questionnaire (SGRQ)
Time frame: Change from Baseline to 3-Months Following Completion of Treatments
Scale is 0-100; a higher score is worse
6 secondary outcomes
Spirometry Testing
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
6 Minute Walk Test
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Leicester Cough Questionnaire (LCQ)
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
COPD Assessment Test (CAT)
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Visual Analog Scale (VAS)
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Modified Medical Research Council (mMRC)
Time frame: Change from Baseline to 3-Months, 1 year, 2 year and 3 year Following Completion of Treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 2604284Thompson AB, Daughton D, Robbins RA, Ghafouri MA, Oehlerking M, Rennard SI. Intraluminal airway inflammation in chronic bronchitis. Characterization and correlation with clinical parameters. Am Rev Respir Dis. 1989 Dec;140(6):1527-37. doi: 10.1164/ajrccm/140.6.1527.
- Background: PubMed 17035444Innes AL, Woodruff PG, Ferrando RE, Donnelly S, Dolganov GM, Lazarus SC, Fahy JV. Epithelial mucin stores are increased in the large airways of smokers with airflow obstruction. Chest. 2006 Oct;130(4):1102-8. doi: 10.1378/chest.130.4.1102.
- Background: PubMed 24493923Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. Int J Chron Obstruct Pulmon Dis. 2014 Jan 24;9:139-50. doi: 10.2147/COPD.S38938. eCollection 2014.
- BackgroundGodwin BL, Coad JE, "Healing responses following cryothermic and hyperthermic tissue ablation. " SPIE Proceedings 2009: Volume 7181, p1-9
- Background: PubMed 20860505Sciurba FC, Ernst A, Herth FJ, Strange C, Criner GJ, Marquette CH, Kovitz KL, Chiacchierini RP, Goldin J, McLennan G; VENT Study Research Group. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010 Sep 23;363(13):1233-44. doi: 10.1056/NEJMoa0900928.
- Background: PubMed 24429129Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.
- Background: PubMed 14695099Gibson PG. Cough is an airway itch? Am J Respir Crit Care Med. 2004 Jan 1;169(1):1-2. doi: 10.1164/rccm.2310009. No abstract available.
- Background: PubMed 14555461Jeffery P, Holgate S, Wenzel S; Endobronchial Biopsy Workshop. Methods for the assessment of endobronchial biopsies in clinical research: application to studies of pathogenesis and the effects of treatment. Am J Respir Crit Care Med. 2003 Sep 15;168(6 Pt 2):S1-17. doi: 10.1164/rccm.200202-150WS. No abstract available.
- BackgroundPulmonary Physiology, Levitzky M. 7th ed. 2007, The McGraw-Hill Companies
- Background: PubMed 24928812Smith BM, Hoffman EA, Rabinowitz D, Bleecker E, Christenson S, Couper D, Donohue KM, Han MK, Hansel NN, Kanner RE, Kleerup E, Rennard S, Barr RG. Comparison of spatially matched airways reveals thinner airway walls in COPD. The Multi-Ethnic Study of Atherosclerosis (MESA) COPD Study and the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS). Thorax. 2014 Nov;69(11):987-96. doi: 10.1136/thoraxjnl-2014-205160. Epub 2014 Jun 13.
- Derived from this study: PubMed 33590989Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
- 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.
Heather Nigro study director
CSA Medical
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RejuvenAir in people with Bronchitis, Chronic and Cryotherapy Effect, run by CSA Medical, Inc. at 3 sites in 3 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Netherlands, 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse and Serious Adverse Events (time frame: Change from Baseline to 3-Months Following Completion of Treatments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483637, which also lists 11 linked publications.
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 23 Feb 2023.