How Effective and Safe Is Bronchial Thermoplasty in "Real Life" Asthmatics Compared to Those Enrolled in Randomized Clinical Trials?

Rita Arrigo,Carla Galeone,Nicola Facciolongo,Giuseppe Failla,Nicola Scichilone,Alba La Sala,Alida Benfante,Salvatore Battaglia

doi:10.1155/2016/9132198

Abstract

There is limited information on the efficacy and safety of bronchial thermoplasty (BT) in real life. We evaluated the outcomes of the randomized clinical trials for BT in severe asthmatics, in whom the exclusion criteria were not strictly controlled. A case series of seven asthmatics (M/F: 4/3; age: 54.6 ± 2.9 years) is reported. Subjects had a statistically significant improvement in AQLQ (from a mean of 3.96 ± 1.1 to 4.5 ± 1.2 and 5.5 ± 0.6 after 6 and 12 months of treatment; p = 0.0007) and in the ACQ score (from 2.77 ± 0.8 to 1.83 ± 1.2 and 1.5 ± 0.8 after 6 and 12 months; p < 0.001). In the year after BT, severe exacerbations, salbutamol use, and OCS use were significantly lower compared with the 1-yr pretreatment period (p < 0.001). No ED visits and hospitalization occurred in the year after BT. No changes in functional parameters were recorded. Our investigation confirms the safety and efficacy of BT in severe asthmatics in real life settings.

Highlights

Bronchial asthma is estimated to affect around 300 million people worldwide, with 5% to 10% of patients suffering from a severe form of the disease that is often refractory to usual treatment [1]
Bronchial thermoplasty is a new FDA-approved treatment of patients with severe asthma; this treatment was developed in order to improve the quality of life and symptom control in patients with severe asthma, reducing the costs associated with the disease
Our observational study replicated in a real life context the findings of the Asthma Intervention Research (AIR) 2 clinical trial [9]

Summary

Introduction

Bronchial asthma is estimated to affect around 300 million people worldwide, with 5% to 10% of patients suffering from a severe form of the disease that is often refractory to usual treatment [1]. Inflammation is the underlying mechanism in asthma, alterations of the airway smooth muscle (ASM) contraction represent the hallmark of the disease. BT is a novel intervention that delivers controlled thermal energy to the airway wall through a dedicated catheter during a series of bronchoscopy procedures that result in a prolonged reduction in ASM mass [3, 4], ameliorating the symptoms of asthma. We attempted to evaluate the effectiveness of BT in a real life sample of individuals suffering from severe asthma undergoing the procedure, by assessing the same primary and secondary outcomes of the main randomized clinical trials for BT

Methods

Results

Conclusion