Bronchial Thermoplasty Global Registry (BTGR): 2-year results

ObjectivesBronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure.DesignThe BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT.SettingEighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and AustraliaParticipantsOne hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator’s opinion, made them inappropriate for BT treatment were excluded.Primary and secondary outcome measuresBaseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT.ResultsSubjects’ baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT).ConclusionsThe BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT.Trial registration numberNCT02104856.

Download Full-text

Bronchial thermoplasty guided by hyperpolarised gas MRI in adults with severe asthma: a 1-year pilot randomised trial

ERJ Open Research ◽

10.1183/23120541.00268-2021 ◽

2021 ◽

pp. 00268-2021

Author(s):

Sarah Svenningsen ◽

Parameswaran Nair ◽

Rachel L Eddy ◽

Marrissa J McIntosh ◽

Melanie Kjarsgaard ◽

...

Keyword(s):

Quality Of Life ◽

Severe Asthma ◽

Randomised Trial ◽

Patient Specific ◽

Similar Proportion ◽

Life Questionnaire ◽

Bronchial Thermoplasty ◽

Mri Guided ◽

And Control

Patient-specific localisation of ventilation defects using hyperpolarised gas magnetic resonance imaging (MRI) introduces the possibility of regionally targeted bronchial thermoplasty (BT) for the treatment of severe asthma. We aimed to demonstrate that BT guided by MRI to ventilation defects reduces the number of radiofrequency activations while resulting in improved asthma quality-of-life and control scores that are non-inferior to standard BT.In a 1-year, pilot randomised-controlled trial, 14 patients with severe asthma who were clinically eligible to receive BT, underwent hyperpolarised gas MRI to characterise ventilation defects and were randomised to MRI-guided or standard BT. Endpoints were improved Asthma Quality-of-Life Questionnaire (AQLQ) and Asthma Control Questionnaire (ACQ) scores, the proportion of AQLQ and ACQ responders and the number of radiofrequency activations and bronchoscopy sessions.Participants who underwent MRI-guided BT received 53% fewer radiofrequency activations compared to those who had standard BT (p=0.003). At 12-months, the mean improvement from baseline was similar in both groups for AQLQ score (MRI-guided n=5, 1.8 [95% CI, 0.1 to 3.5], p=0.04; standard n=7, 0.7 [95% CI, −0.9 to 2.3], p=0.30) (p=0.25) and ACQ-5 score (MRI-guided n=5, −1.4 [95% CI, −2.6 to −0.2], p=0.03; standard n=7, −0.7 [95% CI, −1.3 to 0.0], p=0.04) (p=0.17). A similar proportion of participants in both groups achieved a clinically relevant improvement in AQLQ (MRI-guided, 80%; standard, 71%) and ACQ-5 scores (MRI-guided, 80%; standard, 57%).Hyperpolarised gas MRI-guided BT reduced the number of radiofrequency activations, and resulted in asthma quality-of-life and control improvements at 12-months that were non-inferior to standard BT.

Download Full-text

A 1-day visit in a severe asthma centre: effect on asthma control, quality of life and healthcare use

European Respiratory Journal ◽

10.1183/13993003.00220-2016 ◽

2016 ◽

Vol 48 (3) ◽

pp. 726-733 ◽

Cited By ~ 36

Author(s):

Akke-Nynke van der Meer ◽

Henk Pasma ◽

Wilma Kempenaar-Okkema ◽

Jo-Anneke Pelinck ◽

Myrte Schutten ◽

...

Keyword(s):

Quality Of Life ◽

Asthma Control ◽

Severe Asthma ◽

Life Questionnaire ◽

Healthcare Use ◽

Uncontrolled Asthma ◽

Control Quality ◽

Asthma Patients

Patients with uncontrolled asthma report ongoing symptoms, poor quality-of-life and extensive healthcare use (HCU) and might benefit from management by a specialised severe asthma team. It is unknown whether a one-time evaluation by asthma experts, without long-term supervision by a specialised team, provides favourable outcomes. We evaluated asthma control (Asthma Control Questionnaire; ACQ), quality-of-life (Asthma-related Quality of Life Questionnaire; AQLQ) and HCU before and 1 year after a 1-day visit programme in a severe asthma centre, including a multidisciplinary assessment resulting in a personalised management plan to be implemented by patients own pulmonologists.40 uncontrolled asthma patients completed questionnaires (ACQ, AQLQ, HCU) at baseline, and 6 and 12 months follow-up.ACQ improved from 2.6 (interquartile range 1.7–3.2) to 1.8 (1.2–3.2) (p=0.003) and AQLQ from 4.8 (4.0–5.2) to 5.3 (4.4–6.0) (p<0.001). We found a reduction in patients with ≥2 exacerbations (95% versus 17%; p<0.001), ≥1 emergency room visit (78% versus 37%; p<0.001) and ≥1 hospitalisation (47% versus 10%; p=0.001).Evaluation of uncontrolled asthma patients in a 1-day visit programme in a severe asthma centre resulted in significant improvements in asthma control, quality-of-life and healthcare use after 1 year. This 1-day visit approach seems beneficial for uncontrolled asthma patients and might reduce their dependence on expensive treatment modalities and long-term management in specialised centres.

Download Full-text

Schweres Asthma: Vergleich einer Typ-2-Biomarkerstrategie mit einem Symptom-basierten Algorithmus zur Steuerung der Kortisondosis

Karger Kompass Pneumologie ◽

10.1159/000517864 ◽

2021 ◽

pp. 1-2

Author(s):

Sebastian Böing

Keyword(s):

Asthma Control ◽

Severe Asthma ◽

Patient Choice ◽

Control Group ◽

High Dose ◽

Life Questionnaire ◽

Strategy Group ◽

Corticosteroid Dose ◽

Increased Risk ◽

Secondary Outcomes

Background: Asthma treatment guidelines recommend increasing corticosteroid dose to control symptoms and reduce exacerbations. This approach is potentially flawed because symptomatic asthma can occur without corticosteroid responsive type-2 (T2)-driven eosinophilic inflammation, and inappropriately high-dose corticosteroid treatment might have little therapeutic benefit with increased risk of side-effects. We compared a biomarker strategy to adjust corticosteroid dose using a composite score of T2 biomarkers (fractional exhaled nitric oxide [FENO], blood eosinophils, and serum periostin) with a standardised symptom-risk-based algorithm (control). Methods: We did a single-blind, parallel group, randomised controlled trial in adults (18–80 years of age) with severe asthma (at treatment steps 4 and 5 of the Global Initiative for Asthma) and FENO of less than 45 parts per billion at 12 specialist severe asthma centres across England, Scotland, and Northern Ireland. Patients were randomly assigned (4:1) to either the biomarker strategy group or the control group by an online electronic case-report form, in blocks of ten, stratified by asthma control and use of rescue systemic steroids in the previous year. Patients were masked to study group allocation throughout the entirety of the study. Patients attended clinic every 8 weeks, with treatment adjustment following automated treatment-group-specific algorithms: those in the biomarker strategy group received a default advisory to maintain treatment and those in the control group had their treatment adjusted according to the steps indicated by the trial algorithm. The primary outcome was the proportion of patients with corticosteroid dose reduction at week 48, in the intention-to-treat (ITT) population. Secondary outcomes were inhaled corticosteroid (ICS) dose at the end of the study; cumulative dose of ICS during the study; proportion of patients on maintenance oral corticosteroids (OCS) at study end; rate of protocol-defined severe exacerbations per patient year; time to first severe exacerbation; number of hospital admissions for asthma; changes in lung function, Asthma Control Questionnaire-7 score, Asthma Quality of Life Questionnaire score, and T2 biomarkers from baseline to week 48; and whether patients declined to progress to OCS. A secondary aim of our study was to establish the proportion of patients with severe asthma in whom T2 biomarkers remained low when corticosteroid therapy was decreased to a minimum ICS dose. This study is registered with ClinicalTrials.gov, NCT02717689 and has been completed. Findings: Patients were recruited from Jan 8, 2016, to July 12, 2018. Of 549 patients assessed, 301 patients were included in the ITT population and were randomly assigned to the biomarker strategy group (n = 240) or to the control group (n = 61). 28.4% of patients in the biomarker strategy group were on a lower corticosteroid dose at week 48 compared with 18.5% of patients in the control group (adjusted odds ratio [aOR] 1.71 [95% CI 0.80–3.63]; p = 0.17). In the per-protocol (PP) population (n = 121), a significantly greater proportion of patients were on a lower corticosteroid dose at week 48 in the biomarker strategy group (30.7% of patients) compared with the control group (5.0% of patients; aOR 11.48 [95% CI 1.35–97.83]; p = 0.026). Patient choice to not follow treatment advice was the principle reason for loss to PP analysis. There was no difference in secondary outcomes between study groups and no loss of asthma control among patients in the biomarker strategy group who reduced their corticosteroid dose. Interpretation: Biomarker-based corticosteroid adjustment did not result in a greater proportion of patients reducing corticosteroid dose versus control. Understanding the reasons for patients not following treatment advice in both treatment strategies is an important area for future research. The prevalence of T2 biomarker-low severe asthma was low. Funding: This study was funded, in part, by the Medical Research Council UK.

Download Full-text

Personalised exhaled nitric oxygen fraction (FENO)-driven asthma management in primary care: a FENO subgroup analysis of the ACCURATE trial

ERJ Open Research ◽

10.1183/23120541.00351-2019 ◽

2020 ◽

Vol 6 (3) ◽

pp. 00351-2019

Author(s):

Suzanne Boer ◽

Persijn J. Honkoop ◽

Rik J.B. Loijmans ◽

Jiska B. Snoeck-Stroband ◽

Willem J.J. Assendelft ◽

...

Keyword(s):

Quality Of Life ◽

Primary Care ◽

Asthma Control ◽

Severe Asthma ◽

Controlled Trial ◽

Asthma Management ◽

Medication Usage ◽

Asthma Exacerbations ◽

Related Quality

BackgroundThe aim of this study was to identify patients who benefit most from exhaled nitric oxide fraction (FENO)-driven asthma management in primary care, based on prespecified subgroups with different levels of FENO.MethodsWe used data from 179 adults with asthma from a 12-month primary care randomised controlled trial with 3-monthly assessments of FENO, asthma control, medication usage, costs of medication, severe asthma exacerbations and quality of life. In the original study, patients were randomised to either a symptom-driven treatment strategy (controlled asthma (Ca) strategy) or a FENO+symptom-driven strategy (FCa). In both groups, patients were categorised by their baseline level of FENO as low (<25 ppb), intermediate (25–50 ppb) and high (>50 ppb). At 12 months, we compared, for each prespecified FENO subgroup, asthma control, asthma-related quality of life, medication usage, and costs of medication between the Ca and FCa strategy.ResultsWe found a difference between the Ca and FCa strategy for the mean dosage of beclomethasone strategy of 223 µg (95% CI 6–439), p=0.04) and for the total costs of asthma medication a mean reduction of US$159 (95% CI US$33–285), p=0.03) in patients with a low baseline FENO level. No differences were found for asthma control, severe asthma exacerbations and asthma-related quality of life in patients with a low baseline FENO level. Furthermore, in patients with intermediate or high level of FENO, no differences were found.ConclusionsIn primary care, FENO-driven asthma management is effective in patients with a low FENO level, for whom it is possible to down-titrate medication, while preserving asthma control and quality of life.

Download Full-text

Effectiveness and Safety of Bronchial Thermoplasty in Severe Asthma in Clinical Practice in Spain

Biomedicine Hub ◽

10.1159/000492075 ◽

2018 ◽

Vol 3 (3) ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

Luis Puente-Maestu ◽

Milagros Llanos Flores ◽

Paola Benedetti ◽

Ingrid Frías Benzant ◽

Alicia Oliva Ramos ◽

...

Keyword(s):

Clinical Practice ◽

Asthma Control ◽

Severe Asthma ◽

Inhaled Corticosteroids ◽

Invasive Procedure ◽

First Year ◽

Asthma Control Test ◽

Bronchial Thermoplasty ◽

Oral Corticosteroids ◽

Predominantly Female

Background: Bronchial thermoplasty (BT) is a minimally invasive procedure consisting of application of thermal energy into the airways to produce ablation of the hypertrophic smooth muscle. It was approved for use in moderate-severe asthma in Spain in 2010. Objectives: The aims of the present study are to analyze the effectiveness and the safety of BT in clinical practice in our center. Methods: Participants had a confirmed diagnosis of severe asthma and poor control without therapeutic alternative. Effectiveness was measured by comparing exacerbations, admissions rates, asthma control, and medication 1 year prior and 1 year after BT was completed. All complications appearing during the procedure and in the first year were recorded. Results: Patients had a mean age of 51 (SD 8) years and were predominantly female (17/23). The average number of activations per patient was 147 (16). The number of severe exacerbations was reduced by 75% (p < 0.001). A 38% reduction in admissions per year was also observed (p = 0.03). The Asthma Control Test improved by 7.1 (3.7) points (p = 0.018). Before BT, the dose of inhaled corticosteroids was 1,621 (1,015) µg of budesonide-equivalent and the dose of oral corticosteroids was 15 (13) mg of prednisone-equivalent. There was a reduction in 430 (731) µg of budesonide-equivalent (p = 0.02) and 4 (11) mg of prednisone (p = 0.094). No changes in lung function were observed. Complications were related mostly to exacerbation of asthma in the days following the procedure. Conclusions: BT is effective and safe for severe uncontrolled bronchial asthma in real clinical practice.

Download Full-text

A Phase IV, Drug Utilization Surveillance Study to Assess the Clinical Impact of Digital Dose Counter pMDIs On Bronchial Asthma Control: DUSS Analyses (Preprint)

10.2196/preprints.13530 ◽

2019 ◽

Author(s):

Keyword(s):

Asthma Control ◽

Severe Asthma ◽

Bronchial Asthma ◽

Drug Utilization ◽

Real World ◽

Symptom Assessment ◽

Clinical Impact ◽

Surveillance Study ◽

Moderate Intensity ◽

Assessment Score

BACKGROUND Asthma control with Persistent symptoms in India remains a clinical enigma with likely incriminating factors including Non- &/or Pseudo-adherence to the ICS/LABA. USFDA guidance recommends the use of dose-counter pMDIs with further mechanisms to track Adherence & Pseudoadherence in real-world settings OBJECTIVE Digital dose counter pMDIs offers simplified reliable tracking of individual ‘actuated’ dosages with ‘END’ display at the completion of labelled therapeutic aerosol spray. The translational impact on Symptom persistence with likely unwarranted exposure to ‘Step up’ strategy is often prevented if not treated as in these cases of ‘Pseudo’ Severe Asthma .To further assess the real-world acceptance and clinical impact of Digital dose-counter pMDIs, in Bronchial asthma including Poorly or Uncontrolled bronchial asthma cases, an non-interventional, observational study was planned. METHODS A national, retrospective, case cohort analyses as Drug Utilization Surveillance study for Digital pMDIs in Br. asthma was conducted in Sept ’16 for outpatient settings of India. The retrospective analyses was initiated and conducted as per ICH GCP principles and Declaration of Helsinki following study protocol and documents approval by local Ethics committee approval with subsequent Clinical Trial Registry of India registration. RESULTS Consecutive cases of Moderate to Severe asthma with uncontrolled status (n=4575) with baseline and follow-up status for at least one GINA symptom assessment score on Digital dose-counter pMDIs from 500 centers across India were available for analyses. Asthma control was assessed as Partly (4575) and Uncontrolled status (2942) cases respectively. Per protocol analyses for Uncontrolled Asthma control group evaluated by GINA symptom assessment score was further assessed for Well controlled status at 8th week in 92.7 % cases (2727/2942) for above group. Adverse events (106, 2%) of mild to moderate intensity were reported. Nebulization was required in two cases with episodic breathlessness and discharged with no consequent sequelae. Post hoc analyses for baseline poorly controlled cases who ‘Switched’ exclusively on Digital dose-counter pMDIs monotherapy or combination with Xanthines or LAMAs showed ‘Well control’ asthma status of 85.9% (p=0.044) , 95.4% (p=0.048), 80.3% (p=0.28). The patient acceptability criteria for ‘Empty’ canister well correlated with the clinical strategy to identify and avoid Pseudoadherence in baseline poorly controlled or difficult –to- treat asthma cases especially in the patients who ‘Switched’ exclusively to Digital pMDIs (582) demonstrating responses viz. ‘Use till Twenty dose display’ (41.6%, ‘Use till END display (53.2%), ‘Use till LAST spray’ (5.1%) CONCLUSIONS Digital pMDIs offers Simple, accurate & reliable tracking of Non- & Pseudoadherence while highlighting incremental Asthma control rates in Severe or Pseudo-Severe Asthma cases before risk assessment for further ‘add-on’ therapy CLINICALTRIAL Registration CTRI/2018/06/014595

Download Full-text

Aerobic training decreases bronchial hyperresponsiveness and systemic inflammation in patients with moderate or severe asthma: a randomised controlled trial

Thorax ◽

10.1136/thoraxjnl-2014-206070 ◽

2015 ◽

Vol 70 (8) ◽

pp. 732-739 ◽

Cited By ~ 86

Author(s):

Andrezza França-Pinto ◽

Felipe A R Mendes ◽

Regina Maria de Carvalho-Pinto ◽

Rosana Câmara Agondi ◽

Alberto Cukier ◽

...

Keyword(s):

Quality Of Life ◽

Severe Asthma ◽

Asthma Exacerbation ◽

Aerobic Training ◽

Bronchial Hyperresponsiveness ◽

Secondary Outcome ◽

Life Questionnaire ◽

Breathing Exercises ◽

Clinical Control

BackgroundThe benefits of aerobic training for the main features of asthma, such as bronchial hyperresponsiveness (BHR) and inflammation, are poorly understood. We investigated the effects of aerobic training on BHR (primary outcome), serum inflammatory cytokines (secondary outcome), clinical control and asthma quality of life (Asthma Quality of Life Questionnaire (AQLQ)) (tertiary outcomes).MethodsFifty-eight patients were randomly assigned to either the control group (CG) or the aerobic training group (TG). Patients in the CG (educational programme+breathing exercises (sham)) and the TG (same as the CG+aerobic training) were followed for 3 months. BHR, serum cytokine, clinical control, AQLQ, induced sputum and fractional exhaled nitric oxide (FeNO) were evaluated before and after the intervention.ResultsAfter 12 weeks, 43 patients (21 CG/22 TG) completed the study and were analysed. The TG improved in BHR by 1 doubling dose (dd) (95% CI 0.3 to 1.7 dd), and they experienced reduced interleukin 6 (IL-6) and monocyte chemoattractant protein 1 (MCP-1) and improved AQLQ and asthma exacerbation (p<0.05). No effects were seen for IL-5, IL-8, IL-10, sputum cellularity, FeNO or Asthma Control Questionnaire 7 (ACQ-7; p>0.05). A within-group difference was found in the ACQ-6 for patients with non-well-controlled asthma and in sputum eosinophil and FeNO in patients in the TG who had worse airway inflammation.ConclusionsAerobic training reduced BHR and serum proinflammatory cytokines and improved quality of life and asthma exacerbation in patients with moderate or severe asthma. These results suggest that adding exercise as an adjunct therapy to pharmacological treatment could improve the main features of asthma.Trial registration numberNCT02033122.

Download Full-text

Rationale, baseline characteristics and methodology of the non-interventional VIVA study in postmenopausal osteoporosis

Osteologie/Osteology ◽

10.1055/s-0037-1620027 ◽

2014 ◽

Vol 23 (01) ◽

pp. 49-55

Author(s):

L. C. Hofbauer ◽

D. Felsenberg ◽

M. Amling ◽

A. Kurth ◽

P. Hadji

Keyword(s):

Quality Of Life ◽

Postmenopausal Osteoporosis ◽

Primary Outcome ◽

Osteoporosis Treatment ◽

Secondary Outcome ◽

Matched Pairs ◽

Fracture History ◽

Baseline Characteristics ◽

Study Inclusion

SummaryIt is important to understand compliance and persistence with medication use in the clinical practice of osteoporosis treatment. The purpose of this work is to describe the “intravenous ibandronate versus oral alendronate” (VIVA) study, a non-interventional trial to assess the compliance and persistence of osteopenic postmenopausal women with treatment via weekly oral alendronate or intravenous ibandronate (Bonviva®) every three months.4477 patients receiving ibandronate 3 mg i. v. quarterly and 1491 patients receiving alendronate 70 mg orally weekly were included in the study. Matched pairs of 901 subjects in each group were also generated. Matching was performed on the basis of age, body mass index, fracture history at study inclusion, prior treatment with bisphosphonates and the number of concomitant disorders. Secondary outcome measures of osteoporosis related fractures, mobility restriction and pain, analgesia, quality of life questionnaires as well as attitudes to medications were assessed. The primary outcome parameters of compliance and persistence will be tracked in these subjects.At baseline, the entire collectives differed significantly on body weight (less in ibandronate group), duration since osteo - porosis diagnosis (longer in ibandronate), and incidence of prior osteoporotic fracture (higher in ibandronate group). The matched-pairs differed only on mobility restriction and quality of life (both worse in ibandronate group).The results from the VIVA study trial will provide scientific rationale for clinical recommendations in the pharmacological treatment of postmenopausal osteoporosis.

Download Full-text