Chronic BronchitisNCT03385616
Gala Treatment for Chronic Bronchitis in Canada
A study testing Gala Airway Treatment System in people with Chronic Bronchitis and COPD, run by Gala Therapeutics, Inc. at 3 sites in Canada.
Trial summary
Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis in Canada. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Bronchitis, COPD
- 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
- 10 participants
- Where
- 3 sitesCanada
- Study dates
- 24 Aug 2017to 28 Feb 2021
- 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
- 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 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.
- Subject has an FEV1/FVC ration < 0.7.
- Subject has been treated with Long Acting Beta Agonists (LABAs) or Long Acting Muscarinic Antagonists (LAMAs) or both for three months or more.
- 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 three months.
- Subject has MMRC score greater than or equal to 3.
- Subject is taking > 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.
Show all 20Show fewer
- Subject has history of proven lung cancer in last 5 years.
- 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 known airway colonization with resistant organisms including but not limited to pseudomonas, MRSA, B Cepacia, MTB, M abscessus, mucor or any significant fungus.
- 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
3 sites in 1 country.
Canada3 sites
Notre Dame Hospital at CHUM
Montreal, H2L 4M1
IUCPQ Quebec
Québec, G1V 4G5
St. Paul's Hospital Vancouver Centre for Heart Lung Innovation
Vancouver, British Columbia, V6Z 1Y7
About this study
Official title: A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis in Canada
Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis in Canada.
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, COPD
- Being tested
- Gala Airway Treatment System
- 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.
Gala Airway Treatment SystemDevice
Also called GATS
The Gala Airway Treatment system is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with GATS | Experimental | Gala Airway Treatment System (GATS) 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 of serious adverse events associated with the Gala Airway Treatment System through 6 months.
Incidence of 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 - CAT
COPD Assessment Test (CAT) questionnaire
Measured: Through end of study (12-months post-bilateral treatment)
Quality of Life - SGRQ
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
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 posted28 Dec 2017
- Study start24 Aug 2017
- Primary completion30 Jul 2020
- Study completion28 Feb 2021
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 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
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03385616
- Sponsor's protocol ID
- CS004
- Status last verified
- Aug 2021
- First submitted
- 18 Dec 2017
- Last updated
- 4 Aug 2021
- 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 40571054
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. 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 in Canada
- ClinicalTrials.gov ID
- NCT03385616
- Acronym / sponsor ID
- CS004
- Conditions
- Chronic Bronchitis, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gala Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 28 Dec 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 in Canada.
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
| Arm | Type | Receives |
|---|---|---|
| Treatment with GATS | Experimental | Device: Gala Airway Treatment SystemGala Airway Treatment System (GATS) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 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.
- Subject has an FEV1/FVC ration < 0.7.
- Subject has been treated with Long Acting Beta Agonists (LABAs) or Long Acting Muscarinic Antagonists (LAMAs) or both for three months or more.
- Subject has a cigarette smoking history of at least ten packs years.
Key exclusion criteria (20 listed)
- Subject has active respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) or COPD exacerbation within the last three months.
- Subject has MMRC score greater than or equal to 3.
- Subject is taking > 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.
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: GATSThe Gala Airway Treatment system is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. | Device | Treatment with GATS |
Primary outcome
Safety: Incidence of serious adverse events associated with the Gala Airway Treatment System through 6 months.
Time frame: 6 months
Incidence of 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 - 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
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 4 Aug 2021.
- 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.
- 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.
3 sites in 1 country: 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 and COPD, run by Gala Therapeutics, Inc. at 3 sites in Canada.
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 6 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 4 Aug 2021. 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. 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 of 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 NCT03385616, 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 4 Aug 2021.