Bronchial Thermoplasty in Severe Persistent Asthma

Severe Asthma Clinical Trial

— PAS2  

Official title:

Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350336
• Other study ID #: 10-02
• Status: Completed
• Phase: N/A
• Start date: April 7, 2011
• Est. completion date: March 17, 2020

Study information

• Verified date: February 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: March 17, 2020
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß2-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.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Intervention

Device:
• Alair System
Treatment of airways with the Alair System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of Severe Exacerbations	# Severe exacerbations / subject / year	Year 1-5
Secondary	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.	Year 1-5
Secondary	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.	Year 1-5
Secondary	Emergency Room Visits for Respiratory Symptoms Rates	Emergency room visits for respiratory symptoms (rates of emergency room visits)	Year 1-5
Secondary	Subjects With Emergency Room Visits for Respiratory Symptoms	Subjects with Emergency room visits for respiratory symptoms	Year 1-5
Secondary	Hospitalizations for Respiratory Symptoms Rates	(# hospitalizations for respiratory symptoms / subject / year)	Year 1-5
Secondary	Subjects With Hospitalizations for Respiratory Symptoms	Subjects with hospitalizations for respiratory symptoms	Year 1-5
Secondary	Respiratory Serious Adverse Events Rates	The rate of subjects with respiratory serious adverse events (SAEs)	Year 1-5
Secondary	Subjects With Respiratory Serious Adverse Events	Subjects with Respiratory Serious Adverse Events	Year 1-5
Secondary	Pre-bronchodilator FEV1	% Predicted Pre-bronchodilator FEV1	Year 1-5
Secondary	Post-bronchodilator FEV1	% Predicted Post-bronchodilator FEV1	Year 1-5

External Links

•   Bronchial Thermoplasty