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Chronic BronchitisRheSolveNCT04677465

Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis

A study testing RheOx Bronchial Rheoplasty in people with Chronic Bronchitis, run by Gala Therapeutics, Inc. at 37 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to… Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Chronic Bronchitis
What is being tested?
RheOx Bronchial Rheoplasty
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
37 sitesin 5 countries
Study dates
7 Apr 2021to Oct 2025
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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is at least 35 years of age.
  • Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
  • Patient has a CAT score ≥ 10.
  • Patient has an SGRQ score ≥ 25.
  • Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is > 20 points.
  • Patient has FEV1/FVC < 0.70.
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  • Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
  • Patient is receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
  • Patient has a cigarette smoking history of at least ten pack years.
  • In the opinion of the Primary investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule

Who cannot join

  • Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
  • Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.
  • Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
  • Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
  • Patient has unresolved lung cancer.
  • Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
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  • Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable.
  • Patient has emphysema of greater than or equal to 25% as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT Core Lab.
  • Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
  • Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.
  • Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
  • Patient is unable to walk over 225 meters in 6 minutes.
  • Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c >8%), uncontrolled hypertension (diastolic BP >100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).
  • Patient has uncontrolled GERD.
  • Patient has known severe pulmonary hypertension.
  • Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
  • Patient is pregnant, nursing, or planning to get pregnant during study duration.
  • Patient is currently participating in another clinical study involving an investigational product

Trial locations and contacts

37 sites in 5 countries.

37 sites in 5 countries

United States31 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • Syed M. Alam, MD Pulmonology (Bakersfield Heart)

    Bakersfield, California, 93309

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • CHI Memorial Research Center

    Chattanooga, Tennessee, 37404

  • UC Davis Medical Center

    Davis, California, 95817

  • Scripps Health

    Encinitas, California, 92024

  • JPS Health Network, Fort Worth

    Fort Worth, Texas, 76104

  • Houston Methodist

    Houston, Texas, 77030

  • University of Mississippi

    Jackson, Mississippi, 39216

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas School of Medicine

    Kansas City, Kansas, 66160

  • University of Southern California

    Los Angeles, California, 90033

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Norton Thoracic

    Phoenix, Arizona, 85013

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28374

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Virginia Commonwealth University Health

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Honor Health

    Scottsdale, Arizona, 85258

  • The Cardiac and Vascular Institute Research Foundation

    Tallahassee, Florida, 32605

  • UCLA Harbor Lundquist Institute

    Torrance, California, 90502

Other trials in United States

Germany3 sites

  • Charité Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353

  • Ruhrlandklinik Essen

    Essen, 45239

  • Thoraxklinik Heidelberg

    Heidelberg, 69126

Other trials in Germany

Austria1 site

  • Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie

    Vienna, 1210

Other trials in Austria

Italy1 site

  • ASST Spedali Civili Hospital

    Brescia, 25123

Other trials in Italy

United Kingdom1 site

  • Royal Brompton Hospital

    London, SW3 6NP

Other trials in United Kingdom

About this study

Official title: A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD

This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 270 patients will be randomized at up to 40 study centers in the United States, Canada, and Europe.

Being tested
RheOx Bronchial Rheoplasty, Sham Procedure
Keywords
COPD
Medical subject headings
Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RheOx Bronchial RheoplastyDevice

    bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.

  • Sham ProcedureDevice

    staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient)

Study groups in NCT04677465
Study groupRoleWhat they receive
RheOx TreatmentExperimentalNot described
Receives: Device: RheOx Bronchial Rheoplasty
Sham ProcedureSham comparatorNot described
Receives: Device: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COPD Assessment Test (CAT) Score

    Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden

    Measured: 6 months

Secondary outcomes (4)

  1. Distal Airway Volume

    Change from baseline distal airway volume (DAV) at expiration using HRCT scans

    Measured: 6 months

  2. COPD Exacerbations

    Rate of moderate and severe COPD exacerbations

    Measured: 12 months

  3. Goblet Cell Hyperplasia

    change from baseline in mean goblet cell hyperplasia score as determined from airway biopsy samples; the grading scale ranges from 0 to 3, where lower scores represent less goblet cell hyperplasia

    Measured: 1 month

  4. Cough Frequency

    change from baseline in cough frequency (coughs/hour in a 24-hour recording period)

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2020
  2. Study start7 Apr 2021
  3. Primary completionMay 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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
Parallel groups
Model description
Parallel group design randomizing patients in a 2:1 ratio to the treatment vs. sham group. Randomization will be blocked and stratified by site and FEV1 (\<50% vs. \>/= 50%)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04677465
Sponsor's protocol ID
CSP-00006
Acronym
RheSolve
Status last verified
Nov 2022
First submitted
16 Dec 2020
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Krimsky WS, VanderLaan PA, Iding JS, Hunter DW, Hatton BA, Bannan B, Kim V. A quantitative method for assessing treatment-related changes within the airway mucosa in patients with chronic bronchitis. Respir Med. 2025 Jan;236:107889. doi: 10.1016/j.rmed.2024.107889. Epub 2024 Nov 28.

    PubMed 39615802

Questions about this trial

What is this clinical trial studying?

A study testing RheOx Bronchial Rheoplasty in people with Chronic Bronchitis, run by Gala Therapeutics, Inc. at 37 sites in 5 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 18 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Germany, Austria, Italy, 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?

COPD Assessment Test (CAT) Score (time frame: 6 months). 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 NCT04677465, 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 27 Jun 2023.

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