Bronchial Thermoplasty in Severe Persistent Asthma
PAS2
Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma
1 other identifier
interventional
284
2 countries
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2011
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2020
CompletedResults Posted
Study results publicly available
March 5, 2021
CompletedMarch 5, 2021
February 1, 2021
8.6 years
April 15, 2011
January 25, 2021
February 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Subjects Experiencing Severe Exacerbations (Rates)
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.
Year 1 vs. Year 2, 3, 4, 5
Secondary Outcomes (11)
Rates of Severe Exacerbations
Year 1-5
Respiratory Adverse Event Rates
Year 1-5
Subjects With Respiratory Adverse Events
Year 1-5
Emergency Room Visits for Respiratory Symptoms Rates
Year 1-5
Subjects With Emergency Room Visits for Respiratory Symptoms
Year 1-5
- +6 more secondary outcomes
Study Arms (1)
Alair
EXPERIMENTALAlair system
Interventions
Eligibility Criteria
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:
- puffs per day of short-acting bronchodilator, or
- puffs per day of long-acting rescue bronchodilator, or
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, 35294, United States
Yale University Center for Asthma and Airway Disease
New Haven, Connecticut, 06520, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
LSU Health Sciences
New Orleans, Louisiana, 70112, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
HealthPartners Specialty Center, Lung and Sleep Health
Saint Paul, Minnesota, 55103, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
DuBois Regional Medical Center
DuBois, Pennsylvania, 15801, United States
Pennsylvania State Hershey
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Pulmonary Associates of Richmond
Richmond, Virginia, 23225, United States
Franciscan Research Center (St. Joseph Medical Center)
Tacoma, Washington, 98405, United States
MultiCare Pulmonary Specialists
Tacoma, Washington, 98405, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Surrey Memorial Hospital
Surrey, British Columbia, V3T 0G9, Canada
Vancouver General Hospital, University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
Montreal Chest Institute
Montreal, Quebec, H2X 2P4, Canada
Hospital Laval Centre de Pneumologie
Sainte-Foy, Quebec, G1V 4G5, Canada
Related Publications (1)
Chupp G, Kline JN, Khatri SB, McEvoy C, Silvestri GA, Shifren A, Castro M, Bansal S, McClelland M, Dransfield M, Trevor J, Kahlstrom N, Simoff M, Wahidi MM, Lamb CR, Ferguson JS, Haas A, Hogarth DK, Tejedor R, Toth J, Hey J, Majid A, LaCamera P, Fitzgerald JM, Enfield K, Grubb GM, McMullen EA, Olson JL, Laviolette M. Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study. Chest. 2022 Mar;161(3):614-628. doi: 10.1016/j.chest.2021.10.044. Epub 2021 Nov 10.
PMID: 34774528DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- G Mark Grubb
- Organization
- Boston Scientific Corp.
Study Officials
- STUDY DIRECTOR
Thomas S Bowman, MD
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2011
First Posted
May 9, 2011
Study Start
April 7, 2011
Primary Completion
November 12, 2019
Study Completion
March 17, 2020
Last Updated
March 5, 2021
Results First Posted
March 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Following Last Patient Out, when Results are posted.