Safety of Bronchial Thermoplasty Performed With the Alair® System During Two Treatment Sessions to Treat Severe Asthma

NCT00803088 | Withdrawn DMC

• 1 other identifier: 08-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Adverse Event Profile

  3 Months

Study Arms (1)

1

EXPERIMENTAL

Treatment of airways with the Alair System

Device: The Alair System

Interventions

The Alair System DEVICE

Treatment of airways with the Alair System

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 bronchoscopy in the opinion of the Investigator or per hospital guidelines.
• Subject is willing and able to comply with the Study protocol, attending follow-up visits, and requirements for taking and abstaining from medications.

You may not qualify if:

• 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:
• puffs per day of short-acting bronchodilator, or
• puffs per day of long-acting rescue bronchodilator, or
• 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.
• Subject had four or more asthma exacerbations requiring oral steroid pulses in the prior 12 months.
• Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine, benzodiazepines, or other parasympathomimetic agents).
• Subject is undergoing immunosuppressant therapy other than steroids (e.g., methotrexate).
• Subject uses systemic beta-adrenergic blocking agents.
• Subject is an insulin-dependent diabetic.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share