scholarly journals Nocturnal temperature-controlled laminar airflow device for adults with severe allergic asthma: the LASER RCT

2019 ◽  
Vol 23 (29) ◽  
pp. 1-140
Author(s):  
Melissa Kapoor ◽  
Will Storrar ◽  
Lara Balls ◽  
Thomas P Brown ◽  
Adel Mansur ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Asthma Control ◽  
Severe Asthma ◽  
Cost Effective ◽  
Health Technology ◽  
Active Device ◽  
Asthma Exacerbations ◽  
Severe Allergic Asthma ◽  
Secondary Outcomes

Background Severe asthma exacerbations are costly to patients and the NHS, and occur frequently in severely allergic patients. Objective To ascertain whether or not nocturnal temperature-controlled laminar airflow (TLA) device usage over 12 months can reduce severe exacerbations and improve asthma control and quality of life compared with a placebo device, while being cost-effective and acceptable to adults with severe allergic asthma. Design A pragmatic, multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial with qualitative interviews. The trial included an internal pilot with qualitative focus groups. Setting Fourteen hospitals in the UK that manage patients with severe asthma. Participants Adults (16–75 years) with severe, poorly controlled, exacerbation-prone asthma despite high-intensity treatment, and who are sensitised to a perennial indoor aeroallergen. Intervention Nocturnal, home-based TLA treatment using an Airsonett® (Airsonett AB, Ängelholm, Sweden) device. The comparator was a placebo device that was identical to the active device except that it did not deliver the laminar airflow. Participants were allocated 1 : 1 to TLA therapy or placebo, minimised by site, origin of case, baseline severe exacerbation frequency, maintenance oral corticosteroid use and pre-bronchodilator forced expiratory volume in 1 second. Main outcome measures Primary outcome – frequency of severe asthma exacerbations occurring within the 12-month follow-up period, defined as worsening of asthma requiring systemic corticosteroids [≥ 30 mg of prednisolone or equivalent daily (or ≥ 50% increase in dose if on maintenance dose of ≥ 30 mg of prednisolone)] for ≥ 3 days. Secondary outcomes – changes in asthma control, lung function, asthma-specific and global quality of life for participants, adherence to the intervention, device acceptability, health-care resource use and cost-effectiveness. Results Between May 2014 and January 2016, 489 patients consented to participate in the trial, of whom 249 failed screening and 240 were randomised (n = 119 in the treatment group and n = 121 in the placebo group); all were analysed. In total, 202 participants (84%) reported use of the device for 9–12 months. Qualitative analyses showed high levels of acceptability. The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616]. There were no significant differences in secondary outcomes for lung function, except for a reduction in mean daily peak expiratory flow [mean (SD) difference 14.7 l/minute (7.35 l/minute), 95% CI 0.32 to 29.1 l/minute; p = 0.045) for those in the active device group. There were no differences in asthma control or airway inflammation and no serious harms related to the device. No significant difference between the groups in quality-adjusted life-years gained over 1 year was observed. In addition, there was no difference in generic or disease-specific health-related quality of life overall, although statistically significant higher quality of life at month 6 was observed. Increases in quality of life were not sufficient to offset the annual costs associated with use of the TLA device. Limitations Missing outcome data could have resulted in an underestimation of exacerbations and rendered the study inconclusive. Conclusions Within the limits of the data, no consistent benefits of the active device were demonstrated, and the differences observed were not sufficient to make the device cost-effective. The types of patients who may benefit from the TLA device, and the reasons for large reductions in exacerbation frequency in severe asthma trials, which also incorporate other methods of recording exacerbations, need to be explored. Trial registration Current Controlled Trials ISRCTN46346208. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 29. See the NIHR Journals Library website for further project information.

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

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.

scholarly journals e-Monitoring of Asthma Therapy to Improve Compliance in children (e-MATIC): a randomised controlled trial

2016 ◽  
Vol 48 (3) ◽  
pp. 758-767 ◽  
Author(s):  
Erwin C. Vasbinder ◽  
Lucas M.A. Goossens ◽  
Maureen P.M.H. Rutten-van Mölken ◽  
Brenda C.M. de Winter ◽  
Liset van Dijk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Quality ◽  
Asthma Exacerbations ◽  
Sms Reminders ◽  
Randomised Controlled

Real-time medication monitoring (RTMM) is a promising tool for improving adherence to inhaled corticosteroids (ICS), but has not been sufficiently tested in children with asthma. We aimed to study the effects of RTMM with short message service (SMS) reminders on adherence to ICS, asthma control, asthma-specific quality of life and asthma exacerbation rate; and to study the associated cost-effectiveness.In a multicentre, randomised controlled trial, children (aged 4–11 years) using ICS were recruited from five outpatient clinics and were given an RTMM device for 12 months. The intervention group also received tailored SMS reminders, sent only when a dose was at risk of omission. Outcome measures were adherence to ICS (RTMM data), asthma control (childhood asthma control test questionnaire), quality of life (paediatric asthma quality of life questionnaire) and asthma exacerbations. Costs were calculated from a healthcare and societal perspective.We included 209 children. Mean adherence was higher in the intervention group: 69.3%versus57.3% (difference 12.0%, 95% CI 6.7%–17.7%). No differences were found for asthma control, quality of life or asthma exacerbations. Costs were higher in the intervention group, but this difference was not statistically significant.RTMM with tailored SMS reminders improved adherence to ICS, but not asthma control, quality of life or exacerbations in children using ICS for asthma.

scholarly journals Positive behaviour support training for staff for treating challenging behaviour in people with intellectual disabilities: a cluster RCT

2018 ◽  
Vol 22 (15) ◽  
pp. 1-110 ◽  
Author(s):  
Angela Hassiotis ◽  
Michaela Poppe ◽  
Andre Strydom ◽  
Victoria Vickerstaff ◽  
Ian Hall ◽  
...  
Keyword(s):  
Technology Assessment ◽  
Cost Effective ◽  
Health Technology ◽  
Service Users ◽  
Challenging Behaviour ◽  
The Mean ◽  
Secondary Outcomes ◽  
Positive Behaviour Support

Background Preliminary studies have indicated that training staff in Positive Behaviour Support (PBS) may help to reduce challenging behaviour among people with intellectual disability (ID). Objective To evaluate whether or not such training is clinically effective in reducing challenging behaviour in routine care. The study also included longer-term follow-up (approximately 36 months). Design A multicentre, single-blind, two-arm, parallel-cluster randomised controlled trial. The unit of randomisation was the community ID service using an independent web-based randomisation system and random permuted blocks on a 1 : 1 allocation stratified by a staff-to-patient ratio for each cluster. Setting Community ID services in England. Participants Adults (aged > 18 years) across the range of ID with challenging behaviour [≥ 15 Aberrant Behaviour Checklist – Community total score (ABC-CT)]. Interventions Manual-assisted face-to-face PBS training to therapists and treatment as usual (TAU) compared with TAU only in the control arm. Main outcome measures Carer-reported changes in challenging behaviour as measured by the ABC-CT over 12 months. Secondary outcomes included psychopathology, community participation, family and paid carer burden, family carer psychopathology, costs of care and quality-adjusted life-years (QALYs). Data on main outcome, service use and health-related quality of life were collected for the 36-month follow-up. Results A total of 246 participants were recruited from 23 teams, of whom 109 were in the intervention arm (11 teams) and 137 were in the control arm (12 teams). The difference in ABC-CT between the intervention and control arms [mean difference –2.14, 95% confidence interval (CI) –8.79 to 4.51; p = 0.528] was not statistically significant. No treatment effects were found for any of the secondary outcomes. The mean cost per participant in the intervention arm was £1201. Over 12 months, there was a difference in QALYs of 0.076 in favour of the intervention (95% CI 0.011 to 0.140 QALYs) and a 60% chance that the intervention is cost-effective compared with TAU from a health and social care cost perspective at the threshold of £20,000 per QALY gained. Twenty-nine participants experienced 45 serious adverse events (intervention arm, n = 19; control arm, n = 26). PBS plans were available for 33 participants. An independent assessment of the quality of these plans found that all were less than optimal. Forty-six qualitative interviews were conducted with service users, family carers, paid carers and service managers as part of the process evaluation. Service users reported that they had learned to manage difficult situations and had gained new skills, and carers reported a positive relationship with therapists. At 36 months’ follow-up (n = 184), the mean ABC-CT difference between arms was not significant (–3.70, 95% CI –9.25 to 1.85; p = 0.191). The initial cost-effectiveness of the intervention dissipated over time. Limitations The main limitations were low treatment fidelity and reach of the intervention. Conclusions Findings from the main study and the naturalistic follow-up suggest that staff training in PBS as delivered in this study is insufficient to achieve significant clinical gains beyond TAU in community ID services. Although there is an indication that training in PBS is potentially cost-effective, this is not maintained in the longer term. There is increased scope to develop new approaches to challenging behaviour as well as optimising the delivery of PBS in routine clinical practice. Trial registration This study is registered as NCT01680276. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals Correlation between asthma control and quality of life in patients with moderate and severe asthma

2015 ◽  
Vol 8 ◽  
pp. A139
Author(s):  
Mary Jane Lisboa Valory ◽  
Norma Rubini ◽  
Albertina Varandas Capelo ◽  
Eliane Miranda Da Silva ◽  
Fernando Samuel Sion ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Asthma Control ◽  
Severe Asthma

Dysfunctional breathing in patients with severe asthma is associated with poor asthma control and low quality of life

2017 ◽  
Author(s):  
Farnam Barati Sedeh ◽  
Anna Von Bülow ◽  
Vibeke Backer ◽  
Uffe Bødtger ◽  
Ulrik Søes Petersen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Asthma Control ◽  
Severe Asthma ◽  
Dysfunctional Breathing

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

2016 ◽  
Vol 48 (3) ◽  
pp. 726-733 ◽  
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.

scholarly journals Targeting treatable traits in severe asthma: a randomised controlled trial

2019 ◽  
Vol 55 (3) ◽  
pp. 1901509 ◽  
Author(s):  
Vanessa M. McDonald ◽  
Vanessa L. Clark ◽  
Laura Cordova-Rivera ◽  
Peter A.B. Wark ◽  
Katherine J. Baines ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Asthma Control ◽  
Severe Asthma ◽  
Controlled Trial ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Randomised Controlled

RationaleTreatable traits have been proposed as a new paradigm for airway disease management.ObjectivesTo characterise treatable traits in a severe asthma population and to determine the efficacy of targeting treatments to these treatable traits in severe asthma.MethodsParticipants (n=140) with severe asthma were recruited to a cross-sectional study and underwent a multidimensional assessment to characterise treatable traits. Eligible participants with severe asthma (n=55) participated in a 16-week parallel-group randomised controlled trial to determine the feasibility and efficacy of management targeted to predefined treatable traits, compared to usual care in a severe asthma clinic. The patient-reported outcome of health-related quality of life was the trial's primary end-point.Main resultsParticipants with severe asthma had a mean±sd of 10.44±3.03 traits per person, comprising 3.01±1.54 pulmonary and 4.85±1.86 extrapulmonary traits and 2.58±1.31 behavioural/risk factors. Individualised treatment that targeted the traits was feasible and led to significantly improved health-related quality of life (0.86 units, p<0.001) and asthma control (0.73, p=0.01).ConclusionsMultidimensional assessment enables detection of treatable traits and identifies a significant trait burden in severe asthma. Targeting these treatable traits using a personalised-medicine approach in severe asthma leads to improvements in health-related quality of life, asthma control and reduced primary care acute visits. Treatable traits may be an effective way to address the complexity of severe asthma.

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