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BMC Pulm Med. 2011 Feb 11;11:8. doi: 10.1186/1471-2466-11-8.

Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.

Author information

1
Gartnavel General Hospital, University of Glasgow, Glasgow, UK. neil.thomson@glasgow.ac.uk

Abstract

BACKGROUND:

Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure.

METHODS:

Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs) and spirometry data were used to assess long-term safety out to 5 years post-BT.

RESULTS:

45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject) was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,). There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group.

CONCLUSIONS:

The absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV1) over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years.

PMID:
21314924
PMCID:
PMC3045390
DOI:
10.1186/1471-2466-11-8
[Indexed for MEDLINE]
Free PMC Article

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