COPDNCT03892694
Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
A study testing RejuvenAir System in people with COPD and Chronic Bronchitis, run by CSA Medical, Inc. at 2 sites in 2 countries.
Trial summary
To evaluate the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- COPD, 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
- 32 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Feb 2020to 12 Dec 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject is or has been in another clinical investigational study within 6 weeks of enrolment.
- Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
To evaluate the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS).
Read the 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.
- Conditions
- COPD, Chronic Bronchitis
- Being tested
- RejuvenAir System, Sham
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RejuvenAir SystemDevice
Bronchial metered cryospray using RejuvenAir® System.
ShamOther
Sham control procedure
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | MCS Receives: Device: RejuvenAir System |
| Sham Control | Sham comparator | Sham Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-months post treatment
Secondary outcomes (7)
Histopathological examination of endobronchial cryobiopsies to determine Inflammatory cells and subtype density per mm of basement membrane
Proportion of inflammatory cells per mm of basement membrane for Neutrophil and Lymphocyte sequencing (RNA-seq)
Measured: 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
Proportion of epithelial cells per mm of basement membrane for Ciliary and Goblet cells
Measured: 6-months post treatment
Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
Measured: 6-months post treatment
Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
Measured: 6-months post treatment
Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
Measured: 6-months post treatment
Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
Measured: 6-months post treatment
The 6-minute walk tests
The 6-minute walk tests
Measured: 6-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start14 Feb 2020
- Primary completion11 Jul 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pallav Shah, MD, Principal investigator, The Royal Brompton Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892694
- Sponsor's protocol ID
- 022
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Orton CM, Tonkin J, Chan LT, Tana A, Marc ST, Conway F, Baikov AN, Wawman R, Eastwood M, Vijayakumar B, Thornton J, D'Sa L, Hartman JE, Klooster K, Slebos DJ, Robertus JL, Bhavsar PK, Shah PL. Metered cryospray in patients with chronic bronchitis: a mechanistic randomised controlled study. Thorax. 2026 Jul 14:thorax-2026-224822. doi: 10.1136/thorax-2026-224822. Online ahead of print.
PubMed 42448469
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT03892694
- Acronym / sponsor ID
- 022
- Conditions
- COPD, Chronic Bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CSA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 27 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.
To evaluate the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: RejuvenAir SystemMCS |
| Sham Control | Sham comparator | Other: ShamSham |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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 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.
Key exclusion criteria (17 listed)
- 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.
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 SystemBronchial metered cryospray using RejuvenAir® System. | Device | Treatment |
| ShamSham control procedure | Other | Sham Control |
Primary outcome
Goblet cell density
Time frame: 6-months post treatment
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
7 secondary outcomes
Histopathological examination of endobronchial cryobiopsies to determine Inflammatory cells and subtype density per mm of basement membrane
Time frame: 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
Time frame: 6-months post treatment
Transcriptomics: Epithelial gene expression as measured by global gene expression sequencing (RNA-seq)
Time frame: 6-months post treatment
Pulmonary function tests including spirometry, body plethysmography and transfer factors KCO and TLCO
Time frame: 6-months post treatment
Patient reported outcome measures including SGRQ, mMRC, CAT and Cough Questionnaires
Time frame: 6-months post treatment
Health care utilisation assessments including number of respiratory exacerbations, emergency room visits, hospital and intensive care unit admissions related to respiratory adverse events
Time frame: 6-months post treatment
The 6-minute walk tests
Time frame: 6-months post treatment
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 30 Sep 2026.
- Derived from this study: PubMed 42448469Orton CM, Tonkin J, Chan LT, Tana A, Marc ST, Conway F, Baikov AN, Wawman R, Eastwood M, Vijayakumar B, Thornton J, D'Sa L, Hartman JE, Klooster K, Slebos DJ, Robertus JL, Bhavsar PK, Shah PL. Metered cryospray in patients with chronic bronchitis: a mechanistic randomised controlled study. Thorax. 2026 Jul 14:thorax-2026-224822. doi: 10.1136/thorax-2026-224822. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Pallav Shah, MD principal investigator
The Royal Brompton Hospital
2 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 COPD and Chronic Bronchitis, run by CSA Medical, Inc. at 2 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 11 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: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. 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?
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?
Goblet cell density (time frame: 6-months post treatment). 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 NCT03892694, which also lists 1 linked publication.
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 30 Sep 2026.