Bronchial Thermoplasty in Severe Persistent Asthma

Completed · Not applicable

Conditions studied: Severe Asthma

In brief

As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific 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.

Key facts

Study ID: NCT01350336
Run by: Boston Scientific Corporation
People needed: 284
Starts: 2011-04-07
Expected to finish: 2020-03-17
Last updated by the study team: 2021-03-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is an adult between the ages of 18 to 65 years.
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.
Subject has asthma and is taking regular maintenance medication that includes:
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.
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).
Oral corticosteroids (OCS) at a dosage of up to, but not greater than 10mg per day are acceptable.*
Subject has a pre-bronchodilator FEV1 of greater than or equal to 60% of predicted.
Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
Subject is able to undergo outpatient (same day) bronchoscopy in the opinion of the investigator or per hospital guidelines.
Subject has at least 2 days of asthma symptoms in the last 4 weeks.
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.

You may not qualify if…

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.
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:
8 puffs per day of short-acting bronchodilator, or
4 puffs per day of long-acting rescue bronchodilator, or
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.
Subject has a post-bronchodilator FEV1 of less than 65%.
Subject has a history of life-threatening asthma, defined by past intubation for asthma, or ICU admission for asthma within the prior 2 years.
Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year.
Subject has had 4 or more infections of lower respiratory tract (LRTI) requiring antibiotics in the past 12 months.
Subject has had 4 or more pulses of systemic corticosteroids (tablets, suspension or injection) for asthma symptoms in the past 12 months.
Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
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).
Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
Subject currently has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction defect, cardiomyopathy, or stroke.
Subject has a known aortic aneurysm.
Subject has significant co-morbid illness such as cancer, renal failure, liver disease, or cerebral vascular disease.
Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
Subject has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
Subject has coagulopathy (INR > 1.5).
Subject has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.

Where it is running

University of Alabama at Birmingham Lung Health Center — Birmingham, Alabama, United States
Yale University Center for Asthma and Airway Disease — New Haven, Connecticut, United States
University of Chicago — Chicago, Illinois, United States
University of Iowa — Iowa City, Iowa, United States
LSU Health Sciences — New Orleans, Louisiana, United States
St. Elizabeth's Medical Center — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Lahey Clinic — Burlington, Massachusetts, United States
Henry Ford Hospital — Detroit, Michigan, United States
Spectrum Health Hospitals — Grand Rapids, Michigan, United States
HealthPartners Specialty Center, Lung and Sleep Health — Saint Paul, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Duke University — Durham, North Carolina, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
DuBois Regional Medical Center — DuBois, Pennsylvania, United States
Pennsylvania State Hershey — Hershey, Pennsylvania, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
University of Virginia Medical Center — Charlottesville, Virginia, United States
Pulmonary Associates of Richmond — Richmond, Virginia, United States
Franciscan Research Center (St. Joseph Medical Center) — Tacoma, Washington, United States
MultiCare Pulmonary Specialists — Tacoma, Washington, United States
University of Wisconsin — Madison, Wisconsin, United States
Surrey Memorial Hospital — Surrey, British Columbia, Canada
Vancouver General Hospital, University of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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