PURPOSE: Bronchial Thermoplasty, a novel therapeutic bronchoscopic procedure that reduces the amount of airway smooth muscle, has the potential to decrease asthma symptoms due to bronchoconstriction. A randomized, multicenter study (Asthma Intervention Research [AIR] Trial), examined the effect of Bronchial Thermoplasty on asthma status of moderate to severe-persistent asthmatics after they were destabilized by limiting their asthma medication to inhaled corticosteroids(ICS) alone.
METHODS: 108 subjects taking ≥200μg beclomethasone equivalent and long-acting-β2-agonists (LABA), with Pre-BD FEV1 ≥60% and ≤85% predicted, and methacholine PC20 <8mg/mL were enrolled at 10 centers. Control group(n=53) received standard medical management alone, and Bronchial Thermoplasty group(n=55) received standard medical management + Bronchial Thermoplasty. At 12-, 26-, and 52-weeks post-treatment visits, subjects’ asthma was evaluated following a 2-week destabilization period of LABA withdrawal (ICS alone).
RESULTS: Results are given as means±SD(n). Mild exacerbation rates averaged for the three 2-week destabilized follow-up periods (ICS alone) showed a 50% reduction from Baseline in the Bronchial Thermoplasty group compared to Controls (p=0.018 for differences between groups of the change from Baseline). Persistent, significant improvements were observed in the Bronchial Thermoplasty versus Control groups one year following treatment, in amPEF: 42.46 ± 46.86(n=46) versus 11.00 ± 45.59(n=41), p=0.002; Symptom-Free-Days (absolute change from Baseline in %SFD): 39.90 ± 37.88(n=46) versus 13.66 ± 35.16(n=41), p=0.001; Puffs of rescue-medication over 7 days: −8.21 ± 14.96(n=46) versus −1.04 ± 14.63(n=40), p=0.028; AQLQ score: 1.18 ± 1.03(n=48) versus 0.60 ± 1.07(n=44), p=0.009; and ACQ score: −1.10 ± 1.08(n=50) versus −0.47 ± 0.98(n=44), p=0.004.
CONCLUSION: Bronchial Thermoplasty reduced mild exacerbation rates and significantly improved the asthma status of subjects taking inhaled corticosteroids.
CLINICAL IMPLICATIONS: The results suggest that in subjects with moderate to severe persistent asthma taking inhaled corticosteroids, a single intervention with Bronchial Thermoplasty may provide significant and persistent clinical benefit.
DISCLOSURE: Michel Laviolette, Other The AIR Trial was funded by Asthmatx, Inc. All payments were made directly to participating Institutions, and not to the Investigators; Product/procedure/technique that is considered research and is NOT yet approved for any purpose, Bronchial Thermoplasty for asthma.