A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Washington University School of Medicine
Sponsor:
Collaborators:
The Cleveland Clinic
National Jewish Health
University of Arizona
University of Chicago
Information provided by (Responsible Party):
Mario Castro, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01185275
First received: June 21, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers.


Condition Intervention
Asthma
Device: Alair system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma. [ Time Frame: 12 months following last bronchial thermoplasty treatment ] [ Designated as safety issue: No ]
    To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.


Secondary Outcome Measures:
  • Baseline predictors of severe exacerbations [ Time Frame: 12 months following last bronchial thermoplasty treatment ] [ Designated as safety issue: No ]
    To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations, in patients with severe refractory asthma.

  • Baseline predictors of healthcare utilization [ Time Frame: 12 months following last bronchial thermoplasty treatment ] [ Designated as safety issue: No ]
    To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in healthcare utilization, in patients with severe refractory asthma.

  • Baseline predictors of safety of bronchial thermoplasty [ Time Frame: 12 months following last bronchial thermoplasty treatment ] [ Designated as safety issue: Yes ]
    To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.

  • Predictive models of response to bronchial thermoplasty [ Time Frame: 12 months following last bronchial thermoplasty treatment ] [ Designated as safety issue: No ]
    To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.


Biospecimen Retention:   Samples With DNA

DNA and RNA extraction, serum, plasma and sputum


Estimated Enrollment: 190
Study Start Date: August 2010
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Severe Asthma Patients
Severe asthma patients symptomatic despite high dose inhaled corticosteroid and long acting beta-agonist
Device: Alair system
Bronchial thermoplasty

Detailed Description:

Primary Aim To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.

Secondary Aims

  1. To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations or healthcare utilization, in patients with severe refractory asthma.
  2. To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.
  3. To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject Population - Severe Refractory Asthma

Criteria

Inclusion Criteria:

  1. Males or females age 18 or greater and less than 65
  2. Subject has asthma and is taking regular maintenance medication for past 12 months that includes:

    • Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per day or equivalent, AND long acting ß2-agonist (LABA) at a dosage of ≥100μg per day Salmeterol or equivalent.
    • 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. Asthma confirmed by: (a) b-agonist reversibility of FEV1 ≥ 12 % following 360mcg albuterol OR (b) methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving an ICS or ≤ 16 mg/ml if receiving an ICS.
  4. FEV1 ≥ 50% predicted pre-bronchodilator.
  5. Asthma symptoms on at least two days or one night per week over the last 2 weeks.
  6. Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
  7. Ability to undergo bronchoscopy in the opinion of the investigator.
  8. Ability and willingness to provide informed consent.
  9. For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.

Exclusion Criteria:

  1. Asthma exacerbation (ED visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks.
  2. Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for asthma in the previous year.
  3. Chronic oral steroid therapy greater than 30 mg per day
  4. Respiratory tract infection within past 4 weeks
  5. Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
  6. Subject is undergoing immunosuppressant therapy (e.g., methotrexate).
  7. Subject is on anticoagulant medication.
  8. Subject has bleeding diathesis, platelet dysfunction, and thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR > 1.5).
  9. Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis).
  10. Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
  11. Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke.
  12. Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
  13. Subject uses an internal or external pacemaker or cardiac defibrillator.
  14. Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency
  15. History of cigarette smoking with > 10 pack years total
  16. Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study
  17. Any condition or compliance issue which in the opinion of the investigator might interfere with participation in the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185275

Contacts
Contact: Tammy Koch, RN 314-747-3063 tkoch@dom.wustl.edu

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States
Contact: Afshin Sam, MD, MSc    520-626-1047    asam@deptofmed.arizona.edu   
Principal Investigator: Afshin Sam, MD, MSc         
Sub-Investigator: James Knepler, MD         
Sub-Investigator: Jamie Goodwin, PhD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Ali I Musani, MD    303-398-1455    Musania@njhealth.org   
Principal Investigator: Ali I Musani, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kyle Hogarth, MD    773-702-9660    dhogarth@uchicago.edu   
Principal Investigator: Kyle Hogarth, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Mario Castro    314-362-6904    castrom@wustl.edu   
Contact: Tammy Koch    314-747-3063    tkoch@wustl.edu   
Sub-Investigator: Alex Chen, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Serpil C Erzurum, MD    216-445-7191    erzurus@ccf.org   
Principal Investigator: Serpil C Erzurum, MD         
Sponsors and Collaborators
Washington University School of Medicine
The Cleveland Clinic
National Jewish Health
University of Arizona
University of Chicago
Investigators
Principal Investigator: Mario Castro, MD, MPH Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Mario Castro, Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01185275     History of Changes
Other Study ID Numbers: 10-0716
Study First Received: June 21, 2010
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

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 August 20, 2014