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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
284
Treatment of airways with the Alair System
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.
Time frame: Year 1 vs. Year 2, 3, 4, 5
Rates of Severe Exacerbations
\# Severe exacerbations / subject / year
Time frame: Year 1-5
Respiratory Adverse Event Rates
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.
Time frame: Year 1-5
Subjects With Respiratory Adverse Events
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.
Time frame: Year 1-5
Emergency Room Visits for Respiratory Symptoms Rates
Emergency room visits for respiratory symptoms (rates of emergency room visits)
Time frame: Year 1-5
Subjects With Emergency Room Visits for Respiratory Symptoms
Subjects with Emergency room visits for respiratory symptoms
Time frame: Year 1-5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 17 more locations
Hospitalizations for Respiratory Symptoms Rates
(# hospitalizations for respiratory symptoms / subject / year)
Time frame: Year 1-5
Subjects With Hospitalizations for Respiratory Symptoms
Subjects with hospitalizations for respiratory symptoms
Time frame: Year 1-5
Respiratory Serious Adverse Events Rates
The rate of subjects with respiratory serious adverse events (SAEs)
Time frame: Year 1-5
Subjects With Respiratory Serious Adverse Events
Subjects with Respiratory Serious Adverse Events
Time frame: Year 1-5
Pre-bronchodilator FEV1
% Predicted Pre-bronchodilator FEV1
Time frame: Year 1-5
Post-bronchodilator FEV1
% Predicted Post-bronchodilator FEV1
Time frame: Year 1-5