A Multicenter Clinical Trial Evaluating the Safety of Bronchial Thermoplasty Performed With the Alair® System During Two Treatment Sessions to Treat Severe Asthma.

Boston Scientific Corporation0 sitesDecember 5, 2008

ConditionsAsthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: Boston Scientific Corporation
Primary Endpoint: Adverse Event Profile
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objective of this multicenter, single-arm, open-label clinical study is to evaluate the safety of performing bronchial thermoplasty with the Alair® System during two treatment sessions to treat severe asthma.

Registry

clinicaltrials.gov

Start Date

December 5, 2008

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is an adult between the ages of 18 to 70 years.
•Subject is able to read, understand, and sign a written Informed Consent form to participate in the Study.
•Subject has asthma and is taking maintenance asthma medication that includes:
•Inhaled corticosteroid (ICS) at a dosage ≥1000μg beclomethasone per day or equivalent, AND long acting β2-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).
•Oral corticosteroids (OCS) at a dosage up to, but not greater than, 10mg per day.
•Subject has an AQLQ score at Baseline of 6.25 or less.
•Subject has a Pre-bronchodilator FEV1 of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
•Subject has a PC20 \< 8mg/ml per methacholine inhalation test using standardized methods\*.
•Subject has at least one day of asthma symptoms during the 2 weeks of the Baseline Diary Period.

Exclusion Criteria

•Subject participated in another clinical trial within 6 weeks of the Baseline Period involving respiratory intervention that could affect the outcome measures of this Study.
•Subject requirement during the Baseline Diary period 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.
•Subject has a post-bronchodilator FEV1 of less than 65% of predicted.
•Subject had three or more hospitalizations for exacerbations of asthma in the prior 12 months.
•Subject has a recent history of life-threatening asthma, defined by at least one intubation for asthma within the past five years.
•Subject had an ICU admission for asthma within the prior 24 months.
•Subject had four or more infections of the lower respiratory tract requiring antibiotics in the prior 12 months.