Bronchial thermoplasty, Bronchoscopy, Asthma, {"type":"clinical-trial","attrs":{"text":"NCT01350336","term_id":"NCT01350336"}}, {"type":"clinical-trial","attrs":{"text":"NCT01777360","term_id":"NCT01777360"}}. Before received more than $100,001 from Asthmatx in consultancy fees. government site. Find products, medical specialty information, and education opportunities. Long-term effects of bronchial thermoplasty on airway smooth muscle and reticular basement membrane thickness in severe asthma. Nguyen DV, Murin S. Bronchial artery pseudoaneurysm with major hemorrhage after bronchial thermoplasty. Bronchoscopy in asthma is known to worsen symptoms and potentially induce complications, even more so in severe asthma (38). Adams DC, Hariri LP, Miller AJ, Wang Y, Cho JL, Villiger M, et al. R.M.N. The improvement in the AQLQ score of 1.35 1.10 in the BT group is consistent with changes that were previously observed after BT in patients with moderate to severe asthma (5) and in patients with severe-persistent asthma (6). Enrollment began in October 2005, and a 12-month follow-up of the last subject was completed in July 2008. Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, et al. This is exemplified by the results of the RISA trial, in which patients with a lower FEV1 were BT treated, as compared to the pivotal AIR2 trial. Bronchoscopic pictures of a bronchial thermoplasty treatment of a right upper lobe. Bronchial thermoplasty (BT) is a novel intervention for asthma that delivers controlled thermal energy to the airway wall during a series of bronchoscopy procedures, resulting in a prolonged reduction in airway smooth muscle (ASM) mass (1, 2).Increased mass and contractility of ASM augments asthma morbidity by causing greater bronchoconstriction and airflow obstruction (). The burden of asthma in the United States: level and distribution are dependent on interpretation of the National Asthma Education and Prevention Program guidelines. Bronchial thermoplasty is an innovative, new, non-drug procedure developed for the treatment of severe persistent asthma. This expectation was based on literature reports of typical placebo responses of 40 to 60% (30) compared with AQLQ changes after BT in prior clinical trials (5, 6). Bronchial thermoplasty is a novel intervention for asthma that delivers controlled thermal energy to the airway wall during a series of bronchoscopy procedures. Second, despite optimal maintenance asthma therapy including possible biologics, potential BT candidates' asthma remains uncontrolled; they have daily symptoms as measured by asthma control test (ACT) and/or ACQ and recurrent/frequent exacerbations, which results in a major burden on their quality of life as measured by an asthma-related quality-of-life questionnaire (e.g., AQLQ). 1Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, Missouri; 2Irmandade Santa Casa de Misericrdia da Porto Alegre, Porto Alegre, Brazil; 3Laval Hospital, Laval University, Quebec, Canada; 4Hospital So Lucas da PUCRS, Porto Alegre, Brazil; 5Hospital Universitrio Clementino Fraga Filho, Rio de Janeiro, Brazil; 6Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom; 7Faculdade de Medicina do ABC, Santo Andr, Sao Paulo, Brazil; 8Montreal Chest Institute, Montreal, Quebec, Canada; 9Gartnavel General Hospital, University of Glasgow, Glasgow, United Kingdom; 10University Hospital of South Manchester and University of Manchester, Manchester, United Kingdom; 11Glenfield General Hospital, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom; 12Henry Ford Medical Center, Detroit, Michigan; 13Pulmonary and Medical Associate of Northern Virginia, Arlington, Virginia; 14HealthPartners Specialty Center, St. Paul, Minnesota; 15Division of Pulmonary and Critical Care Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California; 16Department of Pulmonary Diseases, Universtair Medisch Centrum, Groningen, the Netherlands; 17Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; 18Respiratory Clinical Trials Unit, Royal Adelaide Hospital, Adelaide, Australia; 19Western Australia Lung Research, Sir Charles Gairdner Hospital, Perth, Australia; 20Department of Pulmonary and Critical Care Medicine, Cleveland Clinic, Cleveland, Ohio; 21Baylor College of Medicine, Houston, Texas; 22Division of Pulmonary and Critical Care Medicine, University of Wisconsin, Madison, Wisconsin; 23Duke University Medical Center, Durham, North Carolina; 24Asthmatx, Inc., Sunnyvale, California; 25QST Consultations, Ltd, Allendale, Michigan; 26Berry Consultants, LLC, College Station, Texas; and 27St. Balu A, Ryan D, Niven R. Lung abscess as a complication of bronchial thermoplasty. BT-treated subjects had a substantial decrease in severe exacerbations and ED visits, whereas the BT and sham groups had similar respiratory tract infection rates during the posttreatment period. Expert panel report 3: guidelines for the diagnosis and management of asthma. Refer to PRESCRIPTIVE INFORMATION for Indications for Use, Contraindications, Potential Complications, and Warnings and Precautions. Additional outcomes included the numbers of severe asthma exacerbations (i.e., those requiring systemic corticosteroids or doubling of ICS dose) (16), the percentage of subjects experiencing severe exacerbations, respiratory-related unscheduled physician office visits, emergency department (ED) visits, hospitalizations, and days missed from work/school or other activities due to asthma. Abstract Bronchial thermoplasty (BT) is an interventional bronchoscopic treatment for severe asthma. Bronchial thermoplasty (BT) delivers targeted radiofrequency energy to bronchial airway walls and results in the partial ablation of the airway smooth muscle that is responsible for bronchoconstriction. 2013 Dec; 132(6):1295-302. The rate of upper and lower respiratory tract infections requiring antibiotics was 0.007 0.014 events/subject/wk (24.1% of subjects) in the BT group and 0.006 0.012 events/subject/wk (24.5% of subjects) in the sham group. Furthermore, the anticipation of an upcoming study visit may have heightened expectations in both groups related to the electronic diary data collected for 1 month before the 6- and 12-month study visits. Bronchial thermoplasty is a U.S. Food and Drug Administration-approved medical procedure that treats severe, persistent asthma in adults. The treatment should be performed in a systemic manner, starting at the most distal part of the (sub)segmental airway, then moving proximally to the main bronchi, ensuring that the majority of the airways are treated. Bronchial thermoplasty is an U.S. Food and Drug Administration-approved medical procedure that treats severe, persistent asthma. During bronchoscopy, RF energy activations are delivered using the basket catheter in airways 2 mm or larger, and each activation heats the exposed airway section to approximately 65C. Patients are counselled on this, and increased bronchodilator use, mucous clearance techniques, and extension of augmented OCS may all be required. Furthermore, patients with a recent history of ICU admission with tracheal intubation should be considered as patients at high risk of post-BT complications, but there are no hard data that confirm this. About 5% to 10% of people with asthma have severe asthma that can't be controlled with medications, inhalers or other therapies. The method of Bang and colleagues (17) was used to assess the success of blinding in each of the treatment groups (i.e., the ability of subjects in each group to identify their treatment assignment with greater accuracy than random guessing alone), with P < 0.05 indicating statistical significance. Clinical management of severe therapy-resistant asthma. BT should only be performed in a fully equipped bronchoscopy suite. BT is a clinically proven non-drug therapy for patients with severe asthma, with benefits demonstrated out to 5 years. Asthmatics with uncontrolled comorbidities such as, but not restricted to, cardiovascular and severe renal/liver disorders should not to be treated with BT. For example, anti-IgE can be considered for patients with a predominant allergic phenotype, and anti-IL-5 for patients with a predominant eosinophilic phenotype. Bronchial thermoplasty is approved only to treat adults with severe asthma. This improvement occurred in subjects who were already taking high doses of ICS and LABA and yet is of similar magnitude to that seen in previous asthma studies where subjects were taking less medication (28, 29). Morbidity and mortality weekly report, surveillance for asthma. We believe that in the present study, the preconceived expectations about this promising therapy, together with the care and attention provided by the study staff, contributed to the substantial sham effect. Bronchial Thermoplasty (BT), delivered by the Alair System, is a safe outpatient procedure for adult patients with severe asthma. Typically, selected patients have daily symptoms, and frequent . An increased postprocedural incidence of hospitalizations following BT among subjects whose asthma is very severe was observed. All rights reserved. R.B. This study evaluated the effectiveness and safety of BT in subjects with severe asthma who were symptomatic despite treatment with high doses of ICS and LABA, the current standard of care (18). (Fig.2).2). Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. SUBJECT DEMOGRAPHICS AND BASELINE CHARACTERISTICS (ITT POPULATION). E.F. received $1,001$5,000 from Wyeth in advisory board fees, more than $100,001 from Asthmatx for clinical trial-institutional, $10,001$50,000 from Pfizer, $10,00$50,000 from AstraZeneca, and $5,001$10,000 from GlaxoSmithKline in industry-sponsored grants for clinical trials. d'Hooghe JNS, Ten Hacken NHT, Weersink EJM, Sterk PJ, Annema JT, Bonta PI. has received personal lecture fees from Boston Scientific. Funatsu A, Kobayashi K, Iikura M, Ishii S, Izumi S, Sugiyama H. A case of pulmonary cyst and pneumothorax after bronchial thermoplasty. All values are means SEM. Fuhlbrigge AL, Adams RJ, Guilbert TW, Grant E, Lozano P, Janson SL, et al. Bronchial thermoplasty (BT) is an interventional asthma procedure in which a tube called a bronchoscope is inserted into a person's mouth or nose and threaded through the bronchi (airways) to the lungs. The treatment approach for severe asthma is described in the Global Initiative for Asthma (GINA) guideline steps 4 and 5. Patients with ongoing or recurrent respiratory infections and/or (colonized) bronchiectasis are no good candidates for BT. How does BT work? Conditions and Treatments Bronchial thermoplasty More control over your asthma symptoms Appointments: (904) 244-4075 Adults with severe asthma can now treat their symptoms with bronchial thermoplasty a safe, long-lasting, nondrug procedure approved by the Food and Drug Administration. . received more than $100,001 from Asthamax, Inc. in institutional grants; and $1,001$5,000 each from Novartis, AstraZeneca, and GlaxoSmithKline for lecture fees or advisory boards. Bayesian imputation methods were used to handle missing data in the primary effectiveness analysis, and baseline AQLQ was used as a covariate. Evidence suggests that BT is safe and suitable for people with severe asthma. Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, et al. Improvement in mild exacerbation rate (per patient/week) 0.16 vs. 0.04 (, Improvement in AQLQ, ACQ, morning peak expiratory flow, asthma symptom-free days, and symptom scores, Safety: short-term increase in asthma-related morbidity; long-term improvement, Improvement in AQLQ (1.35 vs. 1.16) (PPS 0.96), Reduction in severe exacerbations, emergency department visits, and days missed from work/school, Stable FEV1 and long-term safety profile including chest HRCT, BT, bronchial thermoplasty; ICS, inhaled corticosteroids; LABA, long-acting -adrenoceptor agonists; OCS, oral corticosteroids; FEV. However, as previously demonstrated (22, 23), a well-conducted sham-controlled study, in which subjects have been adequately informed, is justified (24). (Fig.4b4b). Patients with a high frequency of rescue medication use (> 8 puffs of short-acting 2-adrenergic agonist), potentially reflecting ongoing exacerbation/severe asthma instability, were excluded from the trials. The https:// ensures that you are connecting to the The reduction in exacerbations seen in the first year after treatment remained stable for up to 5 years [7, 8, 9]. The target posterior probability of superiority (PPS) of BT over sham was 95%, except for the primary AQLQ endpoint, where the target PPS was 96.4% (adjusted for two interim looks for early declaration of success). The treatment was administered by an unblinded bronchoscopy team. This study demonstrates a clear effect of BT on improving the asthma-specific quality of life over 1 year despite a larger-than-expected improvement in the sham group. It demonstrated that bronchial thermoplasty is safe, improved quality of life, and decreased frequency of severe exacerbations in the treatment group compared to the control group. The advantage of general anesthesia is the ease of airway and patient management. National Asthma Education and Prevention Program. Accessibility Cox G, Miller JD, McWilliams A, Fitzgerald JM, Lam S. Bronchial thermoplasty for asthma. Consistent with this improvement in asthma, there was an 84% risk reduction in ED visits for respiratory symptoms in the BT group compared with sham group (0.07 vs. 0.43 visits/subject/yr; PPS 99.9%; Figure 3). Methods: Bronchial thermoplasty for severe uncontrolled asthma in Japan. P.I.B. The Global Initiative for Asthma (GINA) guidelines state that BT can be considered as a treatment option for adult asthma patients at step 5. received $1,001$5,000 from Merck Frosst, up to $1,000 from Asthmatx, and $1,001$5,000 from Nycomed in lecture fees for CMA and more than $100,001 from Asthmatx, more than $100,001 from Merck Frosst, $50,001$100,001 from MedImmune, $50,001$100,000 from Broncus, and more than $100,001 from GlaxoSmithKline in industry-sponsored grants for clinical trials. Connolly S, Sheldon R, Thorpe K, Roberts R, Ellenbogen K, Wilkoff B, Morillo C, Gent M, and VPS II. Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, et al. In the clinical BT program, patients were selected at least in part on the evidence of bronchial hyperresponsiveness expressed as a significant response to 2-adrenergic agonists, deterioration on withdrawal from 2-adrenergic agonists, or increased responsiveness to methacholine. In the lower lobes, BT is often initiated in the most distal subsegmental airways, commonly LB/RB 10. No incisions or full anesthesia necessary. b Subsequently, the basket is gently opened by pressing the green handle to provide contact of the 4 struts with the airway wall. All follow-up and assessment visits were conducted by a blinded assessment team. Compliant subjects used the diary to collect baseline data over 4 weeks. Ten subjects were lost to follow-up (nine Alair, one sham). Analysis of blinding assessments indicated that during the posttreatment follow-up period, Assessment physicians were unaware of treatment assignments, and subject beliefs, specifically in the BT group, were unlikely to affect outcome assessments (data not shown). Subjects were evaluated 6 weeks after the last procedure (at the end of the treatment period). Therefore, in practice, the strategy chosen will largely depend on local expertise and availability. Pretolani M, Bergqvist A, Thabut G, Dombret MC, Knapp D, Hamidi F, et al. As the procedure requires advanced bronchoscopy skills, we recommend that only BT-trained (interventional) pulmonologists that regularly perform BT (e.g., > 10 procedures a year) perform this procedure. (BT) has been shown to be an effective and safe additional modality for the management of patients with poorly controlled asthma despite standard therapy [3,4,5]. As there are no comparisons of outcomes between a day case procedure and overnight admission, this decision should be based on local treatment protocols and experience. Watchorn DC, Sahadevan A, Egan JJ, Lane SJ. sharing sensitive information, make sure youre on a federal Debray MP, Dombret MC, Pretolani M, Thabut G, Alavoine L, Brillet PY, et al. In summary, this study demonstrates that BT provides clinically meaningful improvements in severe exacerbations requiring corticosteroids, ED visits, and time lost from work/school during the posttreatment period in patients with severe and inadequately controlled asthma, together with improvements in quality of life. Schematic representation of bronchial thermoplasty procedure. The site is secure. Propofol and remifentanil sedation for bronchial thermoplasty: a prospective cohort trial. Siroux V, Boudier A, Anto J, Cazzoletti L, Accordini S, Alonso J, Cerveri I, Corsico A, Gulsvik A, Jarvis D. Baiardini I, Braido F, Brandi S, Tarantini F, Bonini S, Bousquet P, Zuberbier T, Demoly P, Canonica G. The impact of GINA suggested drugs for the treatment of asthma on health-related quality of life: a GA(2)LEN review.
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