CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Bronchial thermoplasty with the Alair Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00401986
NCT00401986N/ACompleted
CompareCT.gov

Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma

Boston Scientific Corporation·observational·Posted Nov 22, 2006·Updated Feb 1, 2021

In Brief

An observational study evaluating Bronchial thermoplasty with the Alair System for Asthma. Completed, enrolled 14 participants across 8 sites in 3 countries.

Detailed Summary

The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBrazil, Canada, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2006
Enrollment StartJan 1, 2007
Primary CompletionDec 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.6 years ago

Interventions

Bronchial thermoplasty with the Alair Systemdevice

Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).