Effectiveness of bronchial thermoplasty for severe persistent bronchial asthma accompanied by Pseudomonas aeruginosa infection.
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ABSTRACT:
SUBMITTER: Ishii S
PROVIDER: S-EPMC9213246 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundBronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.ObjectiveWe sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.MethodsBT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans.ResultsOne hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT.ConclusionsThese data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.
| S-EPMC4114404 | biostudies-literature
Project description:PurposeBronchial thermoplasty is approved in many countries worldwide as a non-pharmacological treatment for severe asthma. This review summarizes recent publications on the selection of patients with severe asthma for bronchial thermoplasty, predictors of a beneficial response and developments in the procedure and discusses specific issues about bronchial thermoplasty including effectiveness in clinical practice, mechanism of action, cost-effectiveness, and place in management.ResultsBronchial thermoplasty is a treatment option for patients with severe asthma after assessment and management of causes of difficult-to-control asthma, such as nonadherence, poor inhaler technique, comorbidities, under treatment, and other behavioral factors. Patients treated with bronchial thermoplasty in clinical practice have worse baseline characteristics and comparable clinical outcomes to clinical trial data. Bronchial thermoplasty causes a reduction in airway smooth muscle mass although it is uncertain whether this effect explains its efficacy since other mechanisms of action may be relevant, such as alterations in airway epithelial, gland, and/or nerve function; improvements in small airway function; or a placebo effect. The cost-effectiveness of bronchial thermoplasty is greater in countries where the costs of hospitalization and emergency department are high. The place of bronchial thermoplasty in the management of severe asthma is not certain, although some experts propose that bronchial thermoplasty should be considered for patients with severe asthma associated with non-type 2 inflammation or who fail to respond favorably to biologic therapies targeting type 2 inflammation.ConclusionBronchial thermoplasty is a modestly effective treatment for severe asthma after assessment and management of causes of difficult-to-control asthma. Asthma morbidity increases during and shortly after treatment. Follow-up studies provide reassurance on the long-term safety of the procedure. Uncertainties remain about predictors of response, mechanism(s) of action, and place in management of severe asthma.
| S-EPMC6875488 | biostudies-literature
Project description:BackgroundBronchial thermoplasty (BT) is a recently developed treatment for patients with moderate-to-severe asthma. A few studies have suggested the clinical efficacy of this intervention. However, no study has evaluated the cost-effectiveness of BT compared to other alternative treatments for moderate-to-severe allergic asthma, which currently include omalizumab and standard therapy.ObjectiveTo evaluate the cost-effectiveness of standard therapy, BT, and omalizumab for moderate-to-severe allergic asthma in the USA.MethodsA probabilistic Markov model with weekly cycles was developed to reflect the course of asthma progression over a 5-year time horizon. The study population was adults with moderate-to-severe allergic asthma whose asthma remained uncontrolled despite using high-dose inhaled corticosteroids (ICS, with or without long-acting beta-agonists [LABA]). A perspective of the health-care system was adopted with asthma-related costs as well as quality-adjusted life years (QALYs) and exacerbations as the outcomes.ResultsFor standard therapy, BT, and omalizumab, the discounted 5-year costs and QALYs were $15,400 and 3.08, $28,100 and 3.24, and $117,000 and 3.26, respectively. The incremental cost-effectiveness ratio (ICER) of BT versus standard therapy and omalizumab versus BT was $78,700/QALY and $3.86 million/QALY, respectively. At the willingness-to-pay (WTP) of $50,000/QALY and $100,000/QALY, the probability of BT being cost-effective was 9%, and 67%, respectively. The corresponding expected value of perfect information (EVPI) was $155 and $1,530 per individual at these thresholds. In sensitivity analyses, increasing the costs of BT from $14,900 to $30,000 increased its ICER relative to standard therapy to $178,000/QALY, and decreased the ICER of omalizumab relative to BT to $3.06 million/QALY. Reducing the costs of omalizumab by 25% decreased its ICER relative to BT by 29%.ConclusionsBased on the available evidence, our study suggests that there is more than 60% chance that BT becomes cost-effective relative to omalizumab and standard therapy at the WTP of $100,000/QALY in patients with moderate-to-severe allergic asthma. However, there is a substantial uncertainty in the underlying evidence, indicating the need for future research towards reducing such uncertainty.
| S-EPMC4709059 | biostudies-literature
Project description:BackgroundBronchial thermoplasty (BT) is a bronchoscopic treatment for severe asthma, of which the working mechanism and responder profile are partly unknown. The aim of this study is to analyse whether BT alters airway inflammation by epithelial gene expression, inflammatory cell counts and cytokines, and whether this relates to treatment response.MethodsIn this clinical trial, 28 severe asthma patients underwent bronchoscopy before and after treatment to obtain bronchial brushes and bronchoalveolar lavage fluid (BALF) from treated and untreated airways. RNA was extracted from bronchial brushes for transcriptome analysis, and BALF cells and cytokines were analysed. Asthma quality of life questionnaires were used to distinguish responders from non-responders. We compared results before and after treatment, between treated and untreated airways, and between responders and non-responders.ResultsGene expression of airway epithelium related to airway inflammation gene set was significantly downregulated in treated airways compared to untreated airways, although this did not differ for patients before and after treatment. No differences were observed in cell counts and cytokines, neither from the untreated compared to treated airways, nor before and after treatment. At baseline, compared to non-responders, the expression of genes related to glycolysis in bronchial epithelium was downregulated and both BALF and blood eosinophil counts were higher in responders.ConclusionLocal differences in gene sets pertaining to epithelial inflammatory status were identified between treated and untreated airways after treatment, not resulting in changes in differential cell counts and cytokine analyses in BALF. Secondly, baseline epithelial glycolysis genes and eosinophil counts in BALF and blood were different between responders and non-responders. The observations from this study demonstrate the potential impact of BT on epithelial gene expression related to airway inflammation while also identifying a possible responder profile.
| S-EPMC9767029 | biostudies-literature
Project description:BACKGROUND:Bronchial thermoplasty (BT) is a non-pharmacological intervention for severe asthma whose mechanism of action is not completely explained by a reduction of airway smooth muscle (ASM). In this study we analyzed the effect of BT on nerve fibers and inflammatory components in the bronchial mucosa at 1 year. METHODS:Endobronchial biopsies were obtained from 12 subjects (mean age 47 ± 11.3 years, 50% male) with severe asthma. Biopsies were performed at baseline (T0) and after 1 (T1), 2 (T2) and 12 (T12) months post-BT, and studied with immunocytochemistry and microscopy methods. Clinical data including Asthma Quality of Life Questionnaire (AQLQ) and Asthma Control Questionnaire (ACQ) scores, exacerbations, hospitalizations, oral corticosteroids use were also collected at the same time points. RESULTS:A statistically significant reduction at T1, T2 and T12 of nerve fibers was observed in the submucosa and in ASM compared to T0. Among inflammatory cells, only CD68 showed significant changes at all time points. Improvement of all clinical outcomes was documented and persisted at the end of follow up. CONCLUSIONS:A reduction of nerve fibers in epithelium and in ASM occurs earlier and persists at one year after BT. We propose that nerve ablation may contribute to mediate the beneficial effects of BT in severe asthma. TRIAL REGISTRATION:Registered on April 2, 2013 at ClinicalTrials.gov Identifier: NCT01839591 .
| S-EPMC5806286 | biostudies-literature
Project description:Background and objectiveSevere asthma refers to asthma that requires step 4 or 5 therapy recommended by Global Initiative for Asthma (GINA) to prevent it from becoming uncontrolled or remaining "uncontrolled" despite this therapy. The poor treatment effect of severe asthma has been perplexing clinicians, which reduces the quality of life (QoL) of patients with asthma, and increases the mortality of such patients, so improving the therapeutic effect of severe asthma is an urgent problem to be solved in the clinic. Bronchial thermoplasty (BT) is a new non-drug therapy for severe asthma that is difficult to control with medications. It has been approved for clinical practice in China and the United States. The article aims at providing a new treatment option for patients with severe asthma that is poorly controlled by medications, thus improving the QoL in these patients.MethodsAn extensive literature search was performed in the PubMed database, with "bronchial thermoplasty" as the key term. The full texts of all potentially relevant articles were obtained, and relevant information was extracted.Key content and findingsWe find that BT is suitable for patients with severe asthma poorly controlled by medications.ConclusionsThis paper reviews the mechanism of action, procedure, safety and effectiveness, adverse effects and complications, problems, and prospects of BT, with an attempt to guide the practical application of this technique.
| S-EPMC9011210 | biostudies-literature
Project description:BackgroundAsthma is a disease with tremendous phenotypic heterogeneity, and the patients who are most severely impacted by the disease are high utilizers of the United States healthcare system. In the past decade, there has been many advances in asthma therapy for those with severe disease, including the use of a procedure called bronchial thermoplasty (BT) and the use of biologic therapy for certain phenotypes, but questions remain regarding the long-term durability and cost effectiveness of these therapies. The purpose of this analysis was (1) to assess the cost utility of BT relative to usual care (base case) and (2) to assess the cost utility of BT relative to usual care plus biologic therapy (omalizumab) (scenario analysis) based on updated 10-year clinical trial outcomes.MethodsA Markov cohort model was developed and used to estimate the cost utility of BT to estimate the costs and quality-of-life impact of BT versus the comparisons over a 10-year time frame using a limited societal perspective, which included both direct health utilization costs and indirect costs associated with missed days of work, among those with severe persistent asthma.ResultsIn the base case and the scenario analysis, BT was the dominant treatment strategy compared to usual care alone and usual care plus biologic therapy. The net monetary benefit for BT was $483,555.49 over a 10-year time horizon.ConclusionCost-utility models are central to policy decisions dictating coverage, and can be extended to inform the patient and provider, during clinical decision-making, of the relative trade-offs of therapy, assessing long-term clinical and cost outcomes. Phenotypic classification of severe asthma is central to patient management and should also be integrated into economic analysis frameworks, particularly as new biologic agents are developed that are specific to a phenotype. Despite a larger upfront cost of BT therapy, there is a durable clinical and economic benefit over time for those with severe asthma.
| S-EPMC9211745 | biostudies-literature
Project description:Bronchial thermoplasty (BT) is an endoscopic therapy employed for the treatment of refractory asthma. However, no predictive factors are available that determine the effectiveness of BT in treating asthma patients. The present study aimed to comprehensively analyze RNA samples from the airway bronchial tissues of 8 patients with severe asthma treated by BT, and to characterize each patient as a BT responder or non-responder. Total 24 RNA samples (three per patient prior to BT1 [baseline], prior to BT2 [after 1st time treatment], and prior to BT3 [after 2nd time treatment]) were obtained. There were 975 differentially expressed (DE) genes in the bronchial tissues of 8 patients between prior to BT1 (baseline) and prior to BT2 (after 1st time treatment), with significant differences (FDR-adjusted P<0.05). Subjects with an Asthma Quality of Life Questionnaire score change of >0.5 for a period of 12 months were considered BT responders. Non-responders exhibited a score change of <0.5 for 12 months. Transcriptome analysis at baseline identified 67 genes that were differentially expressed between responders and non-responders, including SLPI, MMP3, and MUC19 which were upregulated in responders.
2021-06-22 | GSE159091 | GEO
Project description:Bronchial thermoplasty (BT) is a novel therapy for patients with severe asthma. Using radio frequency thermal energy, it aims to reduce the airway smooth muscle mass. Several clinical trials have demonstrated improvements in asthma-related quality of life and a reduction in the number of exacerbations following treatment with BT. In addition, recent data has demonstrated the long-term safety of the procedure as well as sustained improvements in rates of asthma exacerbations, reduction in health care utilization, and improved quality of life. Further study is needed to elucidate the underlying mechanisms that result in these improvements. In addition, improved characterization of the asthma subphenotypes likely to exhibit the largest clinical benefit is a critical step in determining the precise role of BT in the management of severe asthma.
| S-EPMC4440435 | biostudies-other
Project description:BackgroundBronchial thermoplasty (BT) is an endoscopic treatment for severe asthma targeting airway smooth muscle (ASM) with radiofrequent energy. Although implemented worldwide, the effect of BT treatment on the airways is unclear. Optical coherence tomography (OCT) is a novel imaging technique, based on near-infrared light, that generates high-resolution cross-sectional airway wall images.ObjectiveTo assess the safety and feasibility of OCT in severe asthma patients and determine acute airway effects of BT by OCT and compare these to the untreated right middle lobe (RML).MethodsSevere asthma patients were treated with BT (TASMA trial). During the third BT procedure, OCT imaging was performed immediately following BT in the airways of the upper lobes, the right lower lobe treated 6 weeks prior, and the untreated RML.Results57 airways were imaged in 15 patients. No adverse events occurred. Three distinct OCT patterns were discriminated: low-intensity scattering pattern of (1) bronchial and (2) peribronchial edema and (3) high-intensity scattering pattern of epithelial sloughing. (Peri)bronchial edema was seen in all BT-treated airways, and less pronounced in only 1/3 of the RML airways. These effects extended beyond the ASM layer and more distal than the directly BT-treated areas and were reduced, but not resolved, after 6 weeks. Epithelial sloughing occurred in 11/14 of the BT-treated airways and was absent in untreated RML airways.ConclusionsAcute BT effects can be safely assessed with OCT and 3 distinct patterns were identified. The acute effects extended beyond the targeted ASM layer and distal of directly BT-treated airway areas, suggesting that BT might also target smaller distal airways.
| S-EPMC6390463 | biostudies-literature