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. The effects of Bronchial Thermoplasty on the asthma status of subjects taking inhaled corticosteroids (ICS ≥200μg beclomethasone or equivalent) and long-acting β2-agonists (LABA) as maintenance asthma medications were evaluated in a randomized, multicenter clinical trial.
METHODS: 108 subjects taking the required asthma maintenance medications with Pre-BD FEV1 ≥60% and ≤85% predicted, and methacholine PC20 <8mg/mL were enrolled at 10 centers. The Control group (n=53) received standard medical management alone, and the Bronchial Thermoplasty group (n=55) received standard medical management + Bronchial Thermoplasty. Asthma status was assessed 12-weeks post-treatment by comparing the differences between the groups in the changes from Baseline of various asthma-related parameters.
RESULTS: The Bronchial Thermoplasty group showed an improvement over the Control group in the following parameters (values are means±SD for BT versus Control): amPEF: 23.84 ± 40.46(n=46) versus 1.59 ± 32.11(n=44) L/min, p=0.005; pmPEF: 25.03 ± 37.23(n=45) versus 2.52 ± 30.11(n=44) L/min, p=0.002; Symptom-Free-Days (absolute change from Baseline in %SFD): 20.86 ± 34.68(n=46) versus 6.41 ± 34.57(n=45), p=0.05; Puffs of rescue-medication used over 7 days: -3.44 ± 12.10(n=46) versus 0.44 ± 11.98(n=44), NS; AQLQ score: 0.47 ± 0.94(n=50) versus 0.01 ± 0.90(n=46), p=0.016; ACQ score: −0.29 ± 0.78(n=52) versus −0.01 ± 0.68(n=47), p=0.064. Pre- or Post-BD FEV1 values were unchanged.
CONCLUSION: Bronchial Thermoplasty in asthmatic subjects results in a significant improvement in their asthma status over and above the current standard-of-care, three months following the intervention.
CLINICAL IMPLICATIONS: The results suggest that in subjects with moderate to severe persistent asthma taking current standard-of-care maintenance medication, a single intervention with Bronchial Thermoplasty may provide significant clinical benefit.
DISCLOSURE: Adalberto Rubin, 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.