Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.
BMC Pulm Med
; 11: 8, 2011 Feb 11.
Article
em En
| MEDLINE
| ID: mdl-21314924
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-ß2-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.
Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
Base de dados:
MEDLINE
Assunto principal:
Asma
/
Broncoscopia
/
Pulmão
/
Músculo Liso
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
BMC Pulm Med
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Reino Unido