Bronchial Thermoplasty in Severe Persistent Asthma (PAS2)

This study is currently recruiting participants.
Verified February 2014 by Asthmatx, Inc.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Asthmatx, Inc.
ClinicalTrials.gov Identifier:
NCT01350336
First received: April 15, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

As Conditions of Approval of the PMA for the Alair System, the FDA requires Asthmatx to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.


Condition Intervention Phase
Severe Asthma
Device: Alair System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Asthmatx, Inc.:

Primary Outcome Measures:
  • Subjects experiencing severe exacerbations [ Time Frame: Year 1 vs. Year 2, 3, 4, 5 ] [ Designated as safety issue: No ]
    The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the subsequent 12-month (for Years 2, 3, 4, and 5) compared to the first 12-month after the Alair treatment.


Secondary Outcome Measures:
  • Rates of Severe exacerbations [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    (exacerbations / subject / year)

  • Respiratory adverse events [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the "Respiratory System" that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.

  • Emergency room visits for respiratory symptoms [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    Emergency room visits for respiratory symptoms (rates of emergency room visits)

  • Emergency room visits for respiratory symptoms [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    Emergency room visits for respiratory symptoms (proportion of subjects with emergency room visits for respiratory symptoms)

  • Hospitalizations for respiratory symptoms [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    (hospitalizations/ subject/ year)

  • Hospitalizations for respiratory symptoms [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    (the proportion of subjects with hospitalizations for respiratory symptoms)

  • Respiratory Serious Adverse Events [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    Pre-bronchodilator FEV1

  • Respiratory Serious Adverse Events [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    Post-bronchodilator FEV1


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alair Device: Alair System
Treatment of airways with the Alair System

Detailed Description:

This is a multicenter, open-label, single arm study designed to demonstrate durability of the treatment effect and to evaluate the short-term and longer-term safety profile of the Alair System in the United States in the intended use population (patients 18 years and older with severe persistent asthma).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is an adult between the ages of 18 to 65 years.
  2. Subject is able to read, understand, and sign a written Informed Consent to participate in the study and able to comply with the study protocol.
  3. Subject has asthma and is taking regular maintenance medication that includes:

    1. Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per day or equivalent, AND long acting β2-agonist (LABA) at a dosage of ≥80μg per day Salmeterol or equivalent.
    2. Other asthma medications such as leukotriene modifiers, or anti-IgE, are acceptable (Subjects on Xolair® must have been on Xolair for greater than 1 year).
    3. Oral corticosteroids (OCS) at a dosage of up to, but not greater than 10mg per day are acceptable.*
  4. Subject has a pre-bronchodilator FEV1 of greater than or equal to 60% of predicted.
  5. Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
  6. Subject is able to undergo outpatient (same day) bronchoscopy in the opinion of the investigator or per hospital guidelines.
  7. Subject has at least 2 days of asthma symptoms in the last 4 weeks.
  8. Subject has an AQLQ score during the baseline period of 6.25 or less.

    • NOTE: Subjects on a dosage regimen of 20mg OCS every other day may be included as this is equivalent to an average daily dosage of 10mg.

Exclusion Criteria:

  1. Subject is participating in another clinical trial within 6 weeks of the Baseline Period involving respiratory intervention that could affect the outcome measures of this Study.
  2. Over the last 7 days of a 4 week medication stable period, subject requirement for rescue medication use other than for prophylactic use for exercise exceeds an average of:

    1. 8 puffs per day of short-acting bronchodilator, or
    2. 4 puffs per day of long-acting rescue bronchodilator, or
    3. 2 nebulizer treatments per day. At the discretion of the Principal Investigator, subjects considered as unstable on baseline medications may have medications adjusted and re-evaluated after a 4 week medication stabilization period.
  3. Subject has a post-bronchodilator FEV1 of less than 65%.
  4. Subject has a history of life-threatening asthma, defined by past intubation for asthma, or ICU admission for asthma within the prior 2 years.
  5. Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year.
  6. Subject has had 4 or more infections of lower respiratory tract (LRTI) requiring antibiotics in the past 12 months.
  7. Subject has had 4 or more pulses of systemic corticosteroids (tablets, suspension or injection) for asthma symptoms in the past 12 months.
  8. Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
  9. Subject has other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (asthma, immediate cutaneous reactivity to A. fumigatus, total serum IgE of >1000ng/mL, elevated specific IgE and IgG to A. fumigatus with or without evidence of central bronchiectasis).
  10. Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
  11. Subject currently has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction defect, cardiomyopathy, or stroke.
  12. Subject has a known aortic aneurysm.
  13. Subject has significant co-morbid illness such as cancer, renal failure, liver disease, or cerebral vascular disease.
  14. Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
  15. Subject has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
  16. Subject has coagulopathy (INR > 1.5).
  17. Subject has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350336

Contacts
Contact: Jey Bolt (508) 683-4006 Jeremy.Bolt@bsci.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Lung Health Center Active, not recruiting
Birmingham, Alabama, United States, 35294
United States, Connecticut
Yale University Center for Asthma and Airway Disease Recruiting
New Haven, Connecticut, United States, 06520
Contact: Nicole Grant    203-737-4818    nicole.grant@yale.edu   
Contact: Donna Cook    203-737-4818    donna.cook@yale.edu   
Principal Investigator: Geoffrey Chupp, MD         
Sub-Investigator: Gaetane Michaud, MD         
Sub-Investigator: Lauren Cohn, MD         
Sub-Investigator: Jonathan Puchalski, MD         
Sub-Investigator: Jose Gomez Villalobos, MD         
Sub-Investigator: Peggy Rubio O'Connor, PA         
Sub-Investigator: Kelsey Johnson, PAC-C         
Sub-Investigator: Robyn A. Scatena, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Dana Factor    773-834-8874    dfactor@bsd.uchicago.edu   
Contact: Kathryn Reilly    773-834-8874    kreilly@medicine.bsd.uchicago.edu   
Principal Investigator: Kyle Hogarth, MD         
Sub-Investigator: Amit Mahajan, MD         
Sub-Investigator: Diane Doeing, MD         
Sub-Investigator: Steve White, MD         
Sub-Investigator: Edward Naureckas, MD         
Central DuPage Hospital Withdrawn
Elk Grove Village, Illinois, United States, 60007
United States, Iowa
University of Iowa Active, not recruiting
Iowa City, Iowa, United States, 52242
United States, Louisiana
LSU Health Sciences Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Connie Romaine    504-568-3452    cromai@lsuhsc.edu   
Principal Investigator: Richard Tejedor, MD         
Sub-Investigator: Kyle Happel, MD         
Sub-Investigator: David Welsh, MD         
Sub-Investigator: Matthew Lammi, MD         
United States, Massachusetts
St. Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02135
Contact: Katherine Herrick    617-779-6792    Katherine.Herrick@steward.org   
Principal Investigator: Samaan Rafeq, MD         
Sub-Investigator: Diedre Keogh, RN, ACNP-BC         
Sub-Investigator: Peter La Camera, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Aishatu Aloma    617-632-8386    aaloma@caregroup.org   
Principal Investigator: Adnan Majid, MD         
Sub-Investigator: Erik Folch, MD         
Sub-Investigator: Meghan Fashjian, MD         
Sub-Investigator: Amit Mahajan, MD         
Sub-Investigator: Omar Ibrahim, MD         
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Joyce E Pelletier, CRT    781-744-3706    Joyce.E.Pelletier@lahey.org   
Principal Investigator: Carla Lamb, MD         
Sub-Investigator: Fares Mouchantaf, MD         
Sub-Investigator: Sara Shadchehr, DO         
Sub-Investigator: Ghazwan Acash, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Roel Rolando-Almario    313-916-3558    RAlmari1@hfhs.org   
Principal Investigator: Michael Simoff, MD         
Sub-Investigator: Cynthia Ray, MD         
Sub-Investigator: Javier Diaz-Mendoza, MD         
Spectrum Health Hospitals Active, not recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
HealthPartners Specialty Center, Lung and Sleep Health Recruiting
St. Paul, Minnesota, United States, 55103
Contact: Natalie K Woodruff, BS, RRT    952-967-5493    Natalie.K.Woodruff@HealthPartners.com   
Principal Investigator: Charlene E McEvoy, MD         
Sub-Investigator: Kealy Ham, MD         
Sub-Investigator: Krista Graven, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Tammy Koch    314-747-3063    tkoch@DIM.wustl.edu   
Principal Investigator: Adrian Shifren, MD         
Sub-Investigator: Brenda Patterson, RN, FNP         
Sub-Investigator: Ajay Sheshadri, MD         
Sub-Investigator: Kaharu Sumino, MD         
Sub-Investigator: Kiran Sarikonda, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Emilly Smathers    919-668-3812    Emily.Smathers@duke.edu   
Principal Investigator: Momen Wahidi, MD         
Sub-Investigator: Scott Shofer, MD         
Sub-Investigator: Kamran Mahmood, MD         
Sub-Investigator: Monica Kraft, MD         
United States, Ohio
Akron General Medical Center Withdrawn
Akron, Ohio, United States, 44307
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joanne Baran-Smiley, RN, BSN    216-444-5023    baranj2@ccf.org   
Principal Investigator: Sumita Khatri, MD         
Sub-Investigator: Serpil Erzurum, MD         
Sub-Investigator: Herbert Wiedemann, MD         
Sub-Investigator: Mark Aronica, MD         
Sub-Investigator: Thomas Gildea, MD         
Sub-Investigator: Samar Farha, MD         
Sub-Investigator: Michael Machuzak, MD         
Sub-Investigator: Joseph Cicenia, MD         
Sub-Investigator: Atul Mehta, MD         
Sub-Investigator: Rachel Taliercio, DO         
Sub-Investigator: Francisco Almeida, Jr., MD         
United States, Pennsylvania
DuBois Regional Medical Center Recruiting
Dubois, Pennsylvania, United States, 15801
Contact: Scott Solnosky    814-375-3522    SASolnosky@drmc.org   
Principal Investigator: Sandeep Bansal, MD         
Sub-Investigator: Susan Mitchell, ACNP-BC         
Pennsylvania State Hershey Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Cathy Mende    717-531-4513    cmende@hmc.psu.edu   
Principal Investigator: Jennifer Toth, MD         
Sub-Investigator: Michael Reed, MD         
Sub-Investigator: Timothy Craig, MD         
Sub-Investigator: Christopher Gilbert, DO, MS         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Danielle Frame    215-662-8736    danielle.frame@uphs.upenn.edu   
Principal Investigator: Andrew R Haas, MD, PhD         
Sub-Investigator: Reynold Panettieri, MD         
Sub-Investigator: Michael Sims, MD         
Sub-Investigator: Anil Vachani, MD         
Sub-Investigator: Daniel Sterman, MD         
Sub-Investigator: Anthony LanFranco, MD         
Sub-Investigator: Audreesh Banerjee, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kate Taylor    843-792-2297    taylkat@musc.edu   
Principal Investigator: Gerard Silvestri, MD         
Sub-Investigator: Nicole Tanner, MD         
Sub-Investigator: Nicholas Pastis, MD         
Sub-Investigator: John Huggins, MD         
United States, Texas
University of Texas Medical Branch Withdrawn
Galveston, Texas, United States, 77555
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Hong Zhu, RN, BS,CRC    434-243-7369    HZ3D@hscmail.mcc.virginia.edu   
Principal Investigator: Kyle Enfield, MD         
Sub-Investigator: George Verghese, MD         
Pulmonary Associates of Richmond Recruiting
Richmond, Virginia, United States, 23225
Contact: Laura Lincoln    804-323-7002    llincoln@paraccess.com   
Principal Investigator: Jamie C Hey, MD         
Sub-Investigator: Glenn Giessel, MD         
Sub-Investigator: Cullen Rivers, MD         
Sub-Investigator: Pawanjit Sarna, MD         
Sub-Investigator: Michael Polsky, MD         
United States, Washington
MultiCare Pulmonary Specialists Active, not recruiting
Tacoma, Washington, United States, 98405
Franciscan Research Center (St. Joseph Medical Center) Active, not recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Michelle Wolff, RN,MSN,CCRC    608-263-0524    mjwolff@medicine.wisc.edu   
Principal Investigator: Scott Ferguson, MD         
Sub-Investigator: Mark Regan, MD         
Sub-Investigator: David Sonetti, MD         
Sub-Investigator: Basant K. Sharma, MD         
Canada, British Columbia
Surrey Memorial Hospital Active, not recruiting
Surrey, British Columbia, Canada, V3T 0G9
Vancouver General Hospital, University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Shelley Abercromby    604-875-4111 ext 62500    Shelley.Abercromby@vch.ca   
Contact: Linda Hui, RN       lindahui@mail.ubc.ca   
Principal Investigator: Mark Fitzgerald, MD         
Sub-Investigator: Stephen Lam, MD         
Sub-Investigator: Tawimas Shaipanich, MD         
Sub-Investigator: Jeremy Road, MD         
Canada, Quebec
Montreal Chest Institute Active, not recruiting
Montreal, Quebec, Canada, H2X 2P4
Hospital Laval Centre de Pneumologie Active, not recruiting
Sainte-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Asthmatx, Inc.
Boston Scientific Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Asthmatx, Inc.
ClinicalTrials.gov Identifier: NCT01350336     History of Changes
Other Study ID Numbers: 10-02
Study First Received: April 15, 2011
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014