Chronic BronchitisNCT03107494
Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis
A study testing Gala Airway Treatment System in people with Chronic Bronchitis, run by Gala Therapeutics, Inc. at 2 sites in 2 countries.
Trial summary
Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Bronchitis
- What is being tested?
- Gala Airway Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jan 2017to 30 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.
- Subject's responses to the first two questions of the CAT must sum to at least 7 points.
- Subject has GOLD Stage II chronic obstructive pulmonary disease (COPD) with a preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment. Subjects with a preserved function (FEV1 > 80%) are allowed if the subject has a total CAT score greater than or equal to 10 and the sum of the first two questions of the CAT score sum to at least 7 points.
- Subject has a cigarette smoking history of at least ten packs years.
- Subject in the opinion of the site investigator is able to adhere to and undergo three bronchoscope procedures inclusive of lung biopsies and Gala treatments and has provided a signed informed consent.
Who cannot join
- Subject has active respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) or COPD exacerbation within the last 6 wees prior to study treatment bronchscopy.
- Subject is treated with > 10 mg of prednisolone or prednisone per day.
- Subject has an implantable cardioverter defibrillator or pacemaker.
- Subject has a history of cardiac arrhythmia within past two years.
- Subject has abnormal cardiac rhythm at time of procedure.
- Subject has history of proven lung cancer in last 5 years.
Show all 18Show fewer
- Subject has pulmonary nodule or cavity requiring follow-up or intervention unless proven benign and not actively infected (e.g., aspergilloma).
- Subject has prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy. Pneumothorax without lung resection is acceptable. Pleural procedures without surgery are acceptable.
- Subject has Alpha-1-Antitrypsin (AAT) deficiency.
- Subject has documented history of asthma diagnosed with onset <30 years of age, clinically significant bronchiectasis or any other significant second lung disease.
- Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
- Subject has the inability to walk over 140 meters.
- 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 has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
- 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 on anticoagulation for cardiovascular indications and is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for at least seven days prior to bronchoscopy in the opinion of the Investigator.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis
Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis.
Read the detailed description
The Gala Airway Treatment system is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.
A third bronchoscopy will be performed three months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous.
Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.
- Conditions
- Chronic Bronchitis
- Being tested
- Gala Airway Treatment System
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gala Airway Treatment SystemDevice
Also called GATS, RheOx
The Gala Airway Treatment system is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. In this study, 2 treatment sessions will be delivered 1 month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session. A third bronchoscopy will be performed 3 months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous. Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with GATS | Experimental | Gala Airway Treatment System (GATS) / RheOx Receives: Device: Gala Airway Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months.
Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months.
Measured: 6 months
Secondary outcomes (7)
Clinical Utility - Histology
Histopathological evidence of change in mucus producing cells within the airway.
Measured: 3 months following bilateral treatment
Clinical Utility - Pulmonary Function
Pulmonary function testing (PFT) utilizing Forced Expiratory Volume (FEV1)
Measured: Through end of study (12-months post-bilateral treatment)
Quality of Life - COPD Assessment Test (CAT)
COPD Assessment Test (CAT) questionnaire
Measured: Through end of study (12-months post-bilateral treatment)
Quality of Life - SGRQ
Patient filled respiratory questionnaire: St. George Respiratory Questionnaire (SGRQ)
Measured: Through end of study (12-months post-bilateral treatment)
Acute Exacerbations
Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician)
Measured: From 48 hours post procedure through end of study (12 months post-bilateral treatment)
Non-Acute Exacerbations
Detection of non-acute exacerbations (measured by clinical examination of a suitably qualified physician)
Measured: From 48 hours post procedure through end of study (12 months post-bilateral treatment)
Six Minute Walk Test (6MWT)
Change in 6MWT at 6 months compared to baseline
Measured: 6 months post-bilateral treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start20 Jan 2017
- Primary completion28 Feb 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment with Gala Airway Treatment System (RheOx)
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gala Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Krimsky, MD, Study director, Gala Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107494
- Sponsor's protocol ID
- CS002
- Status last verified
- Aug 2020
- First submitted
- 30 Mar 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Krimsky WS, Mammarappallil JG, Kim V, Bannan B, Charbonnier JP, Hatton BA, Sciurba FC. Airway Mucus Plugging in Chronic Bronchitis and the Impact of Bronchial Rheoplasty. Chest. 2026 Jan;169(1):73-83. doi: 10.1016/j.chest.2025.06.022. Epub 2025 Jun 24.
PubMed 40571054Krimsky 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 39615802Valipour A, Fernandez-Bussy S, Ing AJ, Steinfort DP, Snell GI, Williamson JP, Saghaie T, Irving LB, Dabscheck EJ, Krimsky WS, Waldstreicher J. Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):681-689. doi: 10.1164/rccm.201908-1546OC.
PubMed 32407638
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT03107494
- Acronym / sponsor ID
- CS002
- Conditions
- Chronic Bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gala Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 11 Apr 2017 (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.
Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis.
Detailed description
The Gala Airway Treatment system is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.
A third bronchoscopy will be performed three months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous.
Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with Gala Airway Treatment System (RheOx)
| Arm | Type | Receives |
|---|---|---|
| Treatment with GATS | Experimental | Device: Gala Airway Treatment SystemGala Airway Treatment System (GATS) / RheOx |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.
- Subject's responses to the first two questions of the CAT must sum to at least 7 points.
- Subject has GOLD Stage II chronic obstructive pulmonary disease (COPD) with a preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment. Subjects with a preserved function (FEV1 > 80%) are allowed if the subject has a total CAT score greater than or equal to 10 and the sum of the first two questions of the CAT score sum to at least 7 points.
- Subject has a cigarette smoking history of at least ten packs years.
- Subject in the opinion of the site investigator is able to adhere to and undergo three bronchoscope procedures inclusive of lung biopsies and Gala treatments and has provided a signed informed consent.
Key exclusion criteria (18 listed)
- Subject has active respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) or COPD exacerbation within the last 6 wees prior to study treatment bronchscopy.
- Subject is treated with > 10 mg of prednisolone or prednisone per day.
- Subject has an implantable cardioverter defibrillator or pacemaker.
- Subject has a history of cardiac arrhythmia within past two years.
- Subject has abnormal cardiac rhythm at time of procedure.
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 |
|---|---|---|
| Gala Airway Treatment SystemAlso: GATS, RheOxThe Gala Airway Treatment system is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. In this study, 2 treatment sessions will be delivered 1 month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session. A third bronchoscopy will be performed 3 months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous. Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing. | Device | Treatment with GATS |
Primary outcome
Safety: Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months.
Time frame: 6 months
Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months.
7 secondary outcomes
Clinical Utility - Histology
Time frame: 3 months following bilateral treatment
Clinical Utility - Pulmonary Function
Time frame: Through end of study (12-months post-bilateral treatment)
Quality of Life - COPD Assessment Test (CAT)
Time frame: Through end of study (12-months post-bilateral treatment)
Quality of Life - SGRQ
Time frame: Through end of study (12-months post-bilateral treatment)
Acute Exacerbations
Time frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment)
Non-Acute Exacerbations
Time frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment)
Six Minute Walk Test (6MWT)
Time frame: 6 months post-bilateral 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 1 Sep 2020.
- Derived from this study: PubMed 40571054Krimsky WS, Mammarappallil JG, Kim V, Bannan B, Charbonnier JP, Hatton BA, Sciurba FC. Airway Mucus Plugging in Chronic Bronchitis and the Impact of Bronchial Rheoplasty. Chest. 2026 Jan;169(1):73-83. doi: 10.1016/j.chest.2025.06.022. Epub 2025 Jun 24.
- Derived from this study: PubMed 39615802Krimsky 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.
- Derived from this study: PubMed 32407638Valipour A, Fernandez-Bussy S, Ing AJ, Steinfort DP, Snell GI, Williamson JP, Saghaie T, Irving LB, Dabscheck EJ, Krimsky WS, Waldstreicher J. Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):681-689. doi: 10.1164/rccm.201908-1546OC.
- 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.
William Krimsky, MD study director
Gala Therapeutics, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gala Airway Treatment System in people with Chronic Bronchitis, run by Gala Therapeutics, 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 5 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: finished, as of the sponsor's last update on 1 Sep 2020. 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 Austria, Chile. 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?
Safety: Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months. (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 NCT03107494, which also lists 3 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 1 Sep 2020.