Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis

NCT03107494 | Completed FDA Device

• 1 other identifier: CS002
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief Summary

Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis.

Conditions

Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (7)

• Clinical Utility - Histology

  3 months following bilateral treatment

• Clinical Utility - Pulmonary Function

  Through end of study (12-months post-bilateral treatment)

• Quality of Life - COPD Assessment Test (CAT)

  Through end of study (12-months post-bilateral treatment)

• Quality of Life - SGRQ

  Through end of study (12-months post-bilateral treatment)

• Acute Exacerbations

  From 48 hours post procedure through end of study (12 months post-bilateral treatment)

Other Outcomes (1)

• Cough and Sputum Assessment Questionnaire (CASA-Q)

  Through end of study (12-months post-bilateral treatment)

Study Arms (1)

Treatment with GATS

EXPERIMENTAL

Gala Airway Treatment System (GATS) / RheOx

Device: Gala Airway Treatment System

Interventions

Gala Airway Treatment System DEVICE

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.

Also known as: GATS, RheOx

Treatment with GATS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gala Therapeutics, Inc.: lead

Study Sites (2)

Otto Wagner Spital

Vienna, A-1140, Austria

Location

Clinica Alemana

Santiago, Chile

Location

Related Publications (3)

• 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.

  PMID: 40571054 DERIVED

• 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.

  PMID: 39615802 DERIVED

• Valipour 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.

  PMID: 32407638 DERIVED

MeSH Terms

Conditions

Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Krimsky, MD

  Gala Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment with Gala Airway Treatment System (RheOx)

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: January 20, 2017
• Primary Completion: February 28, 2019
• Study Completion: November 30, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); AU (1)