Efficacy Of Bronchial Thermoplasty Research Articles

Efficacy of bronchial thermoplasty in patients with severe asthma and frequent severe exacerbations: A randomized controlled study✰

BackgroundBronchial thermoplasty (BT) is a bronchoscopic procedure for patients with severe uncontrolled asthma, but randomized controlled studies of its efficacy in severe asthma with frequent exacerbations are lacking. The current aim was to assess BT efficacy in this patient population. MethodsThirty patients with asthma (GINA 5) who had experienced at least four severe exacerbations in the preceding year were randomized to BT (n = 15) or control groups (n = 15). All patients had four follow-up visits over the following 15 months, corresponding to 3, 6, 9, and 12 months after the last procedure for the BT group. The primary outcome was number of exacerbations at 15 months after inclusion (i.e. 12 months after bronchial thermoplasty). ResultsAll but three patients had received an asthma biologic without receiving benefit. In the year preceding enrollment, patients in the BT group had an average of five exacerbations, compared with six among controls. For patients in the BT group, oral steroid intake was 9.3 mg/d, compared with 11.0 mg/d among controls. The BT group had 1.58 fewer severe exacerbations (mean, 6.09) compared with controls (mean, 8.28) in the 12-month period after the therapy (p = 0.047). Oral steroid intake during follow-up after BT was significantly lower in the BT group (ratio vs controls: 0.61; p = 0.0002). Quality-of-life measures between inclusion and the last visit were significantly improved in the BT group, but not among controls. Few mild to moderate adverse events were reported, and all were controlled within days. ConclusionIn patients with severe asthma and frequent severe exacerbations, BT significantly decreased the rate of severe exacerbations and oral steroid intake and led to improved quality of life during the 15 months after inclusion. BT appears to offer a therapeutic option for severe asthma with frequent exacerbations.

Efficacy of bronchial thermoplasty in a patient panel with uncontrolled severe persistent asthma

Background Bronchial thermoplasty (BT) is an approved procedure to manage uncontrolled severe persistent asthma. Many insurance providers are reluctant to pay for BT without proven benefit among their specific patient panel. Objective Determine if BT is effective in a panel patient panel with uncontrolled severe persistent asthma. Study design and methods This was an unblinded prospective study of adult subjects with uncontrolled severe persistent asthma who underwent BT. Outcomes were assessed at baseline and then 3-, 6-, 12-, 18- and 24-months post-BT. The primary metric was an improved Asthma Quality of Life Questionnaire (AQLQ) score. Other metrics included improved Asthma Control Test (ACT), peak expiratory flow rates (PEFR), spirometry, fractional excretion of nitric oxide (FeNO), number of unscheduled medical visits, and lost days of work/activity. Respiratory adverse events were assessed during the BT treatment period and at each post-BT visit. Results Twenty-nine subjects completed the study; the median interquartile range (IQR) age was 47 (42-61), and the majority were female (69%), white (93%), and non-Hispanic (90%). After BT, mean (±std) AQLQ scores improved by 1.6(±1.1) at 3 months (p < 0.0001), 1.6(±1.2) at 6 months (p < 0.0001), 1.4(±1.0) at 12 months (p < 0.0001), 1.8(±1.1) at 18 months (p < 0.0001), and 1.6 (±1.5) at 24 months (p < 0.0001). There were significant improvements in ACT, PEFR, unscheduled medical visits and lost days of work and activity. Spirometry and FeNO metrics were unchanged. The average cost for subjects completing all 3 BT procedures was approximately $15,000. Conclusion BT is an effective adjunctive therapeutic modality in subjects with uncontrolled severe persistent asthma.

Safety and efficacy of bronchial thermoplasty in refractory asthma with severe obstructive respiratory dysfunction.

Bronchial thermoplasty (BT) is a recently developed non-pharmacological therapy for refractory bronchial asthma. Although increasing evidence has suggested that BT is effective for various phenotypes of severe asthma, its safety and efficacy in patients with severe irreversible impaired lung function are unclear. To assess the efficacy and safety of BT in patients with refractory asthma, including patients with a severely impaired forced expiratory volume in 1 second (FEV1). This was a single-center, retrospective, observational cohort study. We retrospectively reviewed the medical records of 15 patients with refractory asthma (Global Initiative for Asthma step 4 or 5), including patients with severely impaired airflow limitation (% predicted pre-bronchodilator FEV1 <60%), who had undergone BT between June 2016 and January 2022. We analyzed the efficacy (change in asthma symptoms, exacerbation rate, pulmonary function, asthma medication, and serum inflammatory chemokine/cytokines before and after BT) and complications in all patients. We compared these data between patients with severe obstructive lung dysfunction [group 1(G1)] and patients with FEV1 ⩾ 60% [group 2 (G2)]. Six patients were in G1 and nine were in G2. Clinical characteristics, T2 inflammation, and concurrent treatment were equivalent in both groups. BT significantly improved asthma-related symptoms (measured using the Asthma Control Test and Asthma Quality of Life Questionnaire scores) in both groups. FEV1 was significantly improved in G1 but not in G2. Four patients in G2, but none in G1, experienced asthma exacerbation requiring additional systemic corticosteroids (including two requiring prolonged hospitalization) after BT. Long-term responders (patients who reduced systemic or inhaled corticosteroid without newly adding biologics in a follow-up > 2 years) of BT were identified in G1 and G2 (n = 2, 33.3% and n = 4, 44.4%, respectively). BT in patients with refractory asthma and severe airflow limitation is equally safe and efficacious as that in patients with moderate airflow limitation.

Safety and efficacy of bronchial thermoplasty in Australia 5 years post-procedure.

Outside clinical trials, there is limited long-term data following bronchial thermoplasty (BT). In a cohort of real-world severe asthmatics in an era of biological therapy, we sought to evaluate the safety and efficacy of BT 5 years post-treatment. Every patient treated with BT at two Australian tertiary centres were recalled at 5 years, and evaluated by interview and record review, Asthma Control Questionnaire (ACQ), spirometry and high-resolution CT Chest. CT scans were interpreted using the modified Reiff and BRICS CT scoring systems for bronchiectasis. Fifty-one patients were evaluated. At baseline, this cohort had a mean age of 59.0 ± 11.8 years, mean ACQ of 3.0 ± 1.0, mean FEV1 of 55.5 ± 18.8% predicted, and 53% were receiving maintenance oral steroids in addition to triple inhaler therapy. At 5 years, there was a sustained improvement in ACQ scores to 1.8 ± 1.0 (p < 0.001). Steroid requiring exacerbation frequency was reduced from 3.8 ± 3.6 to 1.0 ± 1.6 exacerbations per annum (p < 0.001). 44% of patients had been weaned off oral steroids. No change in spirometry was observed. CT scanning identified minor degrees of localized radiological bronchiectasis in 23/47 patients with the modified Reiff score increasing from 0.6 ± 2.6 at baseline to 1.3 ± 2.5 (p < 0.001). However, no patients exhibited clinical features of bronchiectasis, such as recurrent bacterial infection. Sustained clinical benefit from BT at 5 years was demonstrated in this cohort of very severe asthmatics. Mild, localized radiological bronchiectasis was identified in a portion of patients without clinical features of bronchiectasis.

Bronchial thermoplasty improves cough hypersensitivity and cough in severe asthmatics

BackgroundCough is a troublesome symptom of asthma because it is associated with disease severity and poor asthma control. Bronchial thermoplasty (BT) may be effective in improving cough severity and cough-related quality of life in severe uncontrolled asthma. ObjectiveTo evaluate the efficacy of BT for cough in severe uncontrolled asthma. MethodsTwelve patients with severe uncontrolled asthma were enrolled in this study between 2018 May and March 2021 and arbitrarily divided into cough-predominant [cough severity Visual Analog Scale (VAS) ≥ 40 mm, n = 8] and typical asthma (cough VAS <40 mm, n = 4) groups. Clinical parameters, such as capsaicin cough sensitivity [C-CS: the concentrations to inhaled capsaicin required to induce at least two (C2) and five (C5) coughs], lung function, and type-2–related biomarkers (fractional nitric oxides and absolute eosinophil counts) and cough-related indices [cough severity VAS and the Leicester Cough Questionnaire (LCQ)] were evaluated before and 3 months after performing BT. ResultsBT significantly improved both cough-related indices and C-CS in the cough-predominant group. Changes in C-CS were significantly correlated with changes in the LCQ scores (C5: r = 0.65, p = 0.02 for all patients, and r = 0.81, p = 0.01 for the cough-predominant group). ConclusionsBT may be effective for cough in severe uncontrolled asthma by improving C-CS. However, further larger cohort studies are necessary to confirm the effect of BT for cough in asthma. Clinical trial registrationThis study was registered in the UMIN Clinical Trials Registry (Registry ID UMIN: 000031982).

Correlation of Activation Site and Number with the Clinical Response to Bronchial Thermoplasty.

ObjectiveTo investigate the relation of activation site and number with clinical response to bronchial thermoplasty (BT) in refractory asthma patients.MethodsThis work included 106 consecutive refractory asthma patients completing three BT sessions in our hospital from May 2016 to May 2019. Procedure details included recording delivery sites and those in BT. Asthma Control Questionnaire (ACQ) scores and spirometric measurements were recorded 1-day before treatment and 6 months post-treatment to explore the effects of BT activation number and site on clinical response.ResultsACQ score (3.19±1.14 vs 1.26±0.63), forced expiratory volume in 1 sec (FEV1)% predicted (55.53±21.66 vs 66.19±22.50), FEV1 (1.53±0.74 vs 1.93±0.82), and forced vital capacity (FVC) (2.49±0.86 vs 2.92±0.94) significantly increased after three BT sessions compared with pre-session. Major bronchial ablation did not significantly improve BT response in asthma patients. Multivariate logistic regression identified baseline ACQ score and baseline FEV1% predicted as independent factors affecting the clinical response to BT. Correlation and regression analysis revealed a significant linear relationship between baseline ACQ and ACQ improvement, as well as a linear relationship between the third session activation number and ACQ improvement. Based on subgroup analysis of activation number, cohort C (activations ≥ 200) had better lung function, lower non-responding rate, and better long-term effectiveness than the other two cohorts. The activation number in the third BT session showed the strongest predictive ability compared with the first two sessions.ConclusionMain bronchial ablation did not markedly affect clinical response to BT. Baseline ACQ and baseline FEV1% predicted were independent factors affecting clinical response to BT. Increasing the activation number might promote the therapeutic efficacy of BT, and the activation number in the third BT session correlated with and predicted the BT response.

A multicenter study on the safety and efficacy of bronchial thermoplasty in adults with severe asthma.

Background and Aim:Bronchial thermoplasty (BT) is a treatment option for patients with severe asthma. BT involves controlled delivery of radiofrequency energy using a bronchoscopic catheter, thereby reducing bronchial hyperreactivity. Herein, we describe our experience on the safety and efficacy of BT in severe asthma.Methods:This was a retrospective multicenter study of subjects who underwent BT at four centers across India.Results:We included 36 subjects (mean ± standard deviation [SD] age, 50.9 ± 11.5 years, women [69.44%]) undergoing 105 BT treatment sessions. All the subjects met the American Thoracic Society/European Respiratory Society criteria for severe asthma, 22.2% were requiring oral maintenance glucocorticoids. The mean ± SD baseline %predicted forced expiratory volume in one second (FEV1) was 62.07 ± 18.54. The median interquartile range (IQR) annual asthma exacerbation rate in the year preceding BT was 3.5 (1–10). We encountered intraprocedural complications in 7 (6.7%) sessions. An exacerbation of asthma following BT occurred in 6 (5.7%) procedures. We observed a significant improvement in the asthma control test and the asthma control questionnaire scores following BT. The quality of life (asthma quality of life questionnaire) also significantly improved. We noted a significant reduction in the number of exacerbations following BT (median [IQR], 3 [1–10] per year pre-BT versus 0.5 [0–3] per year post-BT, P < 0.001). No significant change occurred in the %predicted FEV1 following BT.Conclusion:BT is a feasible treatment option in patients with severe asthma. More extensive studies are required to establish the efficacy of BT in real-life settings.

Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomised controlled trials

Bronchial thermoplasty is an endoscopic treatment for uncontrolled asthma. Previous randomised clinical trials have shown that bronchial thermoplasty reduces severe exacerbations in people with asthma. However, the long-term efficacy and safety of bronchial thermoplasty beyond 5 years is unknown. The BT10+ study aimed to investigate the efficacy and safety of bronchial thermoplasty after 10 or more years of follow-up. BT10+ was an international, multicentre, follow-up study of participants who were previously enrolled in the AIR, RISA, and AIR2 trials and who had 10 or more years of follow-up since bronchial thermoplasty treatment. Data on patient demographics, quality of life, lung function, CT scans (AIR2 participants only), severe exacerbations, and health-care use during the previous year were collected at the BT10+ 10-year outcomes study visit. The primary effectiveness endpoint was durability of the thermoplasty treatment effect, determined by comparing the proportion of participants who had severe exacerbations during the first and fifth years after bronchial thermoplasty treatment with the proportion of participants who had severe exacerbations during the 12-month period before the BT10+ visit. The primary safety endpoint was the absence of clinically significant post-treatment respiratory image changes after bronchial thermoplasty, defined as bronchiectasis or bronchial stenosis as confirmed by pulmonary volumetric high-resolution CT scan at the BT10+ visit (AIR2 participants only). All analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03243292. The last patient was enrolled on Dec 11, 2018. The last patient completed follow-up on Jan 10, 2019. The BT10+ study enrolled 192 (45%) of the 429 participants who were enrolled in the AIR, RISA, and AIR2 trials. The BT10+ participants comprised 136 who received bronchial thermoplasty (52% of the 260 participants who received bronchial thermoplasty in the original trials), and 56 sham or control participants (33% of 169 from the original trials). 18 (32%) sham or control participants received bronchial thermoplasty after the previous trials concluded. The participants included in BT10+ were followed for 10·8-15·6 years (median 12·1 years) post-treatment. Baseline characteristics were similar between participants enrolled in BT10+ and those not enrolled. Participants treated with bronchial thermoplasty had similar proportions of severe exacerbations at the BT10+ visit (34 [25%] of 136 participants) compared with 1 year (33 [24%] of 135 participants; difference 0·6%, 95% CI -9·7 to 10·8) and 5 years (28 [22%] of 130 participants; difference 3·5%, -6·7% to 13·6) after treatment. Quality of life measurements and spirometry were similar between year 1, year 5, and the BT10+ visit. At the BT10+ study visit, pulmonary high-resolution CT scans from AIR2 participants treated with bronchial thermoplasty showed that 13 (13%) of 97 participants had bronchiectasis. When compared with baseline high-resolution CT scans, six (7%) of 89 participants treated with bronchial thermoplasty who did not have bronchiectasis at baseline had developed bronchiectasis after treatment (5 classified as mild, 1 classified as moderate). Participants treated with bronchial thermoplasty after the original study and participants in the sham or control group also had reductions in severe exacerbations at the BT10+ visit compared with baseline. Our findings suggest that efficacy of bronchial thermoplasty is sustained for 10 years or more, with an acceptable safety profile. Therefore, bronchial thermoplasty is a long-acting therapeutic option for patients with asthma that remains uncontrolled despite optimised medical treatment. Boston Scientific.

Efficacy of bronchial thermoplasty in patients with severe asthma

Objective: To investigate the efficacy and safety of bronchial thermoplasty (BT) in clinical practice in adults with severe, refractory asthma.Methods: Prospective, single-center, open, observational study comprising patients with uncontrolled asthma (asthma control questionnaire (ACQ) >1.5) and/or frequent exacerbations despite treatment with at least high dose inhaled corticosteroids plus a second controller. Efficacy outcomes was change from baseline 4, 8, 12 and 24 months in FEV1, FVC and FEV1/FVC ratio, asthma control questionnaire (ACQ) score and asthma quality of life score (mini-AQLQ). Results are presented as median with interquartile ranges (IQR). The following were recorded as adverse events: Un-scheduled health care contacts, rescue courses of oral corticosteroid (OCS) and/or antibiotics for exacerbation for exacerbations/respiratory tract infections (RTI).Results: Six-teen patients were enrolled (nine males, median age 50 years; 14 followed for 24 months). Compared to baseline, an improvement in FEV1, FVC, FEV1/FVC ratio, mini-AQLQ and ACQ was observed, i.e.FEV1 (IQR) 1.98 L (1.65-2.45) vs. 2.45 L (2.09-2.93) (p = 0.006), FVC (IQR) 3.23 L (2.76-4.05) vs. 3.75 L (3.22-4.36) (p = 0.041), FEV1/FVC 0.60 (IQR: 0.55-0.70) vs. 0.66 (IQR: 0.63-0.71) (p = 0.016), mini-AQLQ 4.0 (IQR: 3.2-4.9) vs. 5.6 (IQR 4.5-6.5) (p = 0.008, and ACQ 2.9 (IQR: 2.1-3.7) versus 1.5 (IQR 1.0-2.4) (p = 0.004). On the other hand, an increase was observed in unscheduled visits (p = 0.005), as well as use of OCS and antibiotics (p = 0.009 and p = 0.003, respectively).Conclusion: BT in adults with severe asthma improved ACQ, mini-AQLQ and lung function, but resulted in an increased frequency of unscheduled doctor-visits and rescue courses of OCS and antibiotics.

Bronchial Thermoplasty Including the Middle Lobe Bronchus Significantly Improves Lung Function and Quality of Life in Patients Suffering from Severe Asthma.

Bronchial Thermoplasty (BT) is indicated in patients suffering from severe and symptomatic bronchial asthma despite maximal medical therapy. However, treatment of the right middle lobe (RML) bronchus is currently not recommended. The aim of this study was to investigate the safety and efficacy of BT if the RML bronchus is included. BT was performed in 17 consecutive patients, quality of life and pulmonary function were characterized before and 90days after BT completion. Furthermore, we performed a clean-up bronchoscopy following every BT. This study was approved by the IRB of the University of Essen (No. 17-7356 BO) and registered as a retrospective observational study at the German Clinical Trials Registry (No. DRKS 00011550). The median baseline values of FEV1 and Asthma Questionnaire of Life Quality (AQLQ) were 1.33l (0.91; 1.73) and 3.01 (2.76; 3.61), respectively, and significantly improved 90days after treatment with FEV 1 at 1.75l (p-value 0.002) and AQLQ 3.8 (p-value < 0.05). Also the amount of oral corticosteroid necessity decreased significantly. No severe adverse events occurred due to the procedure. Clean-up bronchoscopies-when performed-revealed significant fibrinous exudation after every BT procedure. BT including the RML bronchus is feasible. Functionally limited patients with severe asthma could potentially profit. Due to the relevant fibrinous exudation, BT should be followed by clean-up bronchoscopy, not only after RML treatment.

The efficacy and safety of bronchial thermoplasty in severe persistent asthma on extended follow-up.

Asthma is a common condition and there remains a subset of patients who are poorly controlled on maximal therapy. Bronchial thermoplasty (BT) is a bronchoscopic therapy using radiofrequency energy to reduce airway smooth muscle, which has been shown to improve asthma control although further evidence regarding long-term efficacy and safety is required. We aimed to demonstrate safety and efficacy of BT on extended follow-up. Our initial experience with this group was previously reported in 2016, where patients were shown to have a significant improvement in asthma control test (ACT) scores 1-year post-treatment. We carried out a retrospective observational study of seven patients who underwent BT between 2012 and 2013 in an Irish severe asthma centre. The primary endpoint was change in ACT scores from baseline to present. Seven patients underwent BT at a tertiary referral centre in Ireland. ACT scores and data on hospital admissions, exacerbations, maintenance corticosteroid requirements, rescue bronchodilator use and forced expiratory volume for 1 s (FEV1) prior to the procedure and on extended follow-up were collected. Mean follow-up was 49.42 months. A trend towards improvement was seen in median hospitalisations (respective values for median over 12 months 3, 1 P = 0.059) and ACT scores, from 9 to 13 (P = 0.249). Mean FEV1 was 1.68 l prior to treatment and 1.46 l 4 years post-treatment (P = 0.237). There was no mortality among the group. These data support the safety of BT and suggest extended efficacy.

Bronchial Thermoplasty in Severe Asthma

Bronchial thermoplasty (BT) is an endoscopic treatment for severe and uncontrolled asthma. This review provides an overview of the indications, selection criteria, treatment application, and scientific evidence regarding its mechanism of action and safety and efficacy of BT in current clinical practice. It seems that reduction in airway smooth muscle is one of the principal mechanisms of action, since it correlates with clinical benefits. Regarding safety and efficacy, recent case reports and small prospective studies appear to show benefit in more severe asthma patients. Further research is needed to better understand the physiological benefits of BT and select the best candidates for treatment. In order to achieve these goals, experts recommend performing BT only in specialized centers.

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

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.

Bronchial Thermoplasty: Reappraising the Evidence (or Lack Thereof)

Bronchial thermoplasty (BT) involves the application of radiofrequency energy to visible proximal airways to selectively ablate airway smooth muscle. BT is the first nonpharmacologic interventional therapy approved by the US Food and Drug Administration (FDA) for severe asthma. This approval was based on the results of the pivotal Asthma Intervention Research (AIR)-2 trial, which is the only randomized, double-blind, sham-controlled trial of BT. The primary end point of the AIR-2 trial was improvement in the Asthma Quality of Life Questionnaire (AQLQ). The results of the AIR-2 trial have generated enormous interest, controversy, and confusion regarding the true efficacy of BT for severe asthma. Current marketing of BT highlights its use for patients with "severe" asthma, which is interpreted by most practicing clinicians as meaning oral corticosteroid dependence, frequent exacerbations, or a significantly reduced FEV1 with a poor quality of life. Did the AIR-2 trial include patients with a low FEV1, oral steroid dependence, or frequent exacerbations? Did the trial show efficacy for any of the primary or secondary end points? The FDA approved the device based on the reduction in severe asthma exacerbations. However, were the rates of asthma exacerbations, ED visits, or hospitalizations truly different between the two groups, and was this type of analysis even justified given the original study design? This commentary is designed to specifically answer these questions and help the practicing clinician navigate the thermoplasty literature with confidence and clarity. We carefully dissect the design, conduct, and results of the AIR-2 trial and raise serious questions about the efficacy of bronchial thermoplasty.

Point: Efficacy of Bronchial Thermoplasty for Patients With Severe Asthma. Is There Sufficient Evidence? Yes

Point: Efficacy of Bronchial Thermoplasty for Patients With Severe Asthma. Is There Sufficient Evidence? Yes

Point: Efficacy of Bronchial Thermoplasty for Patients With Severe Asthma. Is There Sufficient Evidence? Yes

Point: Efficacy of Bronchial Thermoplasty for Patients With Severe Asthma. Is There Sufficient Evidence? Yes

Safety and Efficacy of Bronchial Thermoplasty in Symptomatic, Severe Asthma

Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control. This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma. Adults who were symptomatic despite treatment with fluticasone or equivalent at more than 750 mug/day, a long-acting beta(2)-agonist, and other medications, which could include 30 mg or less of oral prednisolone/day, were randomized to BT or to a control group. After treatment, subjects entered a 16-week steroid stable phase (Weeks 6-22), a 14-week steroid wean phase (Weeks 22-36), and a 16-week reduced steroid phase (Weeks 36-52). BT resulted in a transient worsening of asthma symptoms. Seven hospitalizations for respiratory symptoms occurred in 4 of 15 BT subjects during the treatment period. Five hospitalizations were within 3 days of treatment. Two subjects had segmental collapse involving the most recently treated lobe; one required bronchoscopy and aspiration of a mucus plug. There were no hospitalizations during this period in the 17 control subjects. The rate of hospitalizations was similar in both groups in the post-treatment period. At 22 weeks, BT subjects had significant improvements versus control subjects in rescue medication use (-26.6 +/- 40.1 vs. -1.5 +/- 11.7 puffs/7 d, P < 0.05), prebronchodilator FEV(1)% predicted (14.9 +/- 17.4 vs. -0.94 +/- 22.3%, P = 0.04), and Asthma Control Questionnaire scores (-1.04 +/- 1.03 vs. -0.13 +/- 1.00, P = 0.02). Improvements in rescue medication use and Asthma Control Questionnaire scores remained significantly different from those of controls at 52 weeks. BT is associated with a short-term increase in asthma-related morbidity. However, there is preliminary evidence of long-lasting improvement in asthma control. Clinical trial registered with www.clinicaltrials.gov (NCT 00214539).

Bronchial Thermoplasty in Refractory Asthma: Interim Results in a Severe Asthma Population (Research in Severe Asthma (RISA) Trial)

RATIONALE: Bronchial Thermoplasty (BT) reduces the amount of airway smooth muscle and potentially bronchoconstriction. The RISA Trial evaluated safety and efficacy of BT in subjects with asthma who were refractory to optimum care in specialty asthma clinics.