Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 60 for:    Gala Therapeutics

Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03107494
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : September 1, 2020
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Treatment with Gala Airway Treatment System (RheOx)
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
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with GATS
Gala Airway Treatment System (GATS) / RheOx
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 Names:
  • GATS
  • RheOx




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: 3 months following bilateral treatment ]
    Histopathological evidence of change in mucus producing cells within the airway.

  2. Clinical Utility - Pulmonary Function [ Time Frame: Through end of study (12-months post-bilateral treatment) ]
    Pulmonary function testing (PFT) utilizing Forced Expiratory Volume (FEV1)

  3. Quality of Life - COPD Assessment Test (CAT) [ Time Frame: Through end of study (12-months post-bilateral treatment) ]
    COPD Assessment Test (CAT) questionnaire

  4. Quality of Life - SGRQ [ Time Frame: Through end of study (12-months post-bilateral treatment) ]
    Patient filled respiratory questionnaire: St. George Respiratory Questionnaire (SGRQ)

  5. Acute Exacerbations [ Time Frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment) ]
    Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician)

  6. Non-Acute Exacerbations [ Time Frame: From 48 hours post procedure through end of study (12 months post-bilateral treatment) ]
    Detection of non-acute exacerbations (measured by clinical examination of a suitably qualified physician)

  7. Six Minute Walk Test (6MWT) [ Time Frame: 6 months post-bilateral treatment ]
    Change in 6MWT at 6 months compared to baseline


Other Outcome Measures:
  1. Cough and Sputum Assessment Questionnaire (CASA-Q) [ Time Frame: Through end of study (12-months post-bilateral treatment) ]
    Patient reported outcome respiratory questionnaire: Cough and Sputum Assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (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's responses to the first two questions of the CAT must sum to at least 7 points.
  3. 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.
  4. Subject has a cigarette smoking history of at least ten packs years.
  5. 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.

Exclusion Criteria:

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

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


Locations
Layout table for location information
Austria
Otto Wagner Spital
Wien, Austria, A-1140
Chile
Clinica Alemana
Santiago, Chile
Sponsors and Collaborators
Gala Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: William Krimsky, MD Gala Therapeutics, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gala Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03107494    
Other Study ID Numbers: CS002
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Bronchitis
Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive