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Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis

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ClinicalTrials.gov Identifier: NCT03107494
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Gala Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Device: Gala Airway Treatment System Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Treatment with Gala Airway Treatment System
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with GATS
Gala Airway Treatment System (GATS)
Device: Gala Airway Treatment System
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.
Other Name: GATS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical Utility - Histology [ Time Frame: 12 months following treatment session number 2 ]
    Histopathological evidence of change in mucus producing cells within the airway.

  2. Clinical Utility - Pulmonary Function [ Time Frame: Pulmonary function testing measured at 1week, 3 months, 6 months and 12 months post treatment number 2 ]
    Pulmonary function testing utilizing the FEV1 and FVC tests

  3. Quality of Life [ Time Frame: Quality of Life Indices will be completed at 1 week post treatment 1, at treatment 2, and 1 week, 3 months, 6 months and 12 months post treatment 2 ]
    Patient filled respiratory questionnaire

  4. Acute Exacerbations [ Time Frame: Between 48 hours post procedure (1st or 2nd treatment procedures and 3rd biopsy procedure) and the end of the patient's participation in the study (up to 1 year following final treatment session) ]
    Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician)



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject has GOLD Stage II chronic obstructive pulmonary disease (COPD) with a preprocedure post-bronchodilator FEV1 of greater than or equal to 50% and less than or equal to 80% of predicted within three months of enrollment.
  3. Subject has been treated with Long Acting Beta Agonists (LABAs) or Long Acting Muscarinic Antagonists (LAMAs) or both for three months or more.
  4. Subject has a cigarette smoking history of at least ten packs years.
  5. Subject in the opinion of the site investigator can undertake the processes and procedures of the clinical trial and has provided a signed informed consent.

Exclusion Criteria:

  1. Subject has active respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) or COPD exacerbation within the last three months.
  2. Subject has MMRC score greater than or equal to 3.
  3. Subject is treated with inhaled corticosteroids (ICS) within the last 4 weeks.
  4. Subject has an implantable cardioverter defibrillator or pacemaker.
  5. Subject has a history of cardiac arrhythmia within past two years.
  6. Subject has abnormal cardiac rhythm at time of procedure.
  7. Subject has history of proven lung cancer in last 5 years.
  8. Subject has pulmonary nodule or cavity requiring follow-up or intervention unless proven benign and not actively infected (e.g., aspergilloma).
  9. 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.
  10. Subject has Alpha-1-Antitrypsin (AAT) deficiency.
  11. Subject has documented history of asthma diagnosed with onset <30 years of age, clinically significant bronchiectasis or any other significant second lung disease.
  12. Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
  13. 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.
  14. Subject has the inability to walk over 140 meters.
  15. 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.
  16. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
  17. Subject is pregnant, nursing, or planning to get pregnant during study duration.
  18. Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
  19. Subject is or has been in another clinical investigational study within 6 weeks of baseline.
  20. 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.

18. Subject is or has been in another clinical investigational study within 6 weeks of baseline.

19.Subject on anticoagulation for cardiovascular indications 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107494


Contacts
Contact: Jonathan Waldstreicher, MD jon@galatherapeutics.com
Contact: Deborah Sheffield, MS deb@galatherapeutics.com

Locations
Austria
Otto Wagner Spital Recruiting
Wien, Austria, A-1140
Contact: Arschang Valipour, MD    0043 664 4385355    blvr.koordinator@gmail.com   
Principal Investigator: Arschang Valiour, MD         
Chile
Clinica Alemana Recruiting
Santiago, Chile
Contact: Carolina Bascuñan    569 934 65819    cbascunan@alemana.cl   
Principal Investigator: Sebastian Fernandez-Bussy, MD         
Sponsors and Collaborators
Gala Therapeutics, Inc.
Investigators
Study Director: Jonathan Waldstreicher, MD Gala Therapeutics, Inc.

Responsible Party: Gala Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03107494     History of Changes
Other Study ID Numbers: CS002
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive