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      Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial

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          Abstract

          Objective

          To determine whether environmental control using nocturnal temperature controlled laminar airflow (TLA) treatment could improve the quality of life of patients with persistent atopic asthma.

          Design

          Randomised, double-blind, placebo-controlled, parallel-group trial.

          Setting

          Nineteen European asthma clinics.

          Participants

          312 patients aged 7–70 with inadequately controlled persistent atopic asthma.

          Main outcome measure

          Proportion of patients with an increase of ≥0.5 points in asthma quality of life score after 1 year of treatment.

          Results

          TLA devices were successfully installed in the bedrooms of 282 (90%) patients included in the primary efficacy analysis. There was a difference in treatment response rate between active (143 of 189, 76%) and placebo (56 of 92, 61%) groups, difference 14.8% (95% CI 3.1 to 26.5, p=0.02). 3 In patients aged ≥12, on whom the study was powered, the difference in response rate was similar-active 106 of 143 (74%), placebo 42 of 70 (60%), difference 14.1% (0.6 to 27.7, p=0.059). There was a difference between groups in fractional exhaled nitric oxide change of −7.1 ppb (−13.6 to −0.7, p=0.03). Active treatment was associated with less increase in cat-specific IgE than placebo. There was no difference in adverse event rates between treatment groups.

          Conclusion

          Inhalant exposure reduction with TLA improves quality of life, airway inflammation and systemic allergy in patients with persistent atopic asthma. TLA may be a treatment option for patients with inadequately controlled persistent atopic asthma.

          Trial registration number

          Clinical Trials NCT00986323.

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          Most cited references19

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          Determining a minimal important change in a disease-specific Quality of Life Questionnaire.

          This study was carried out to determine whether the minimal important difference, in evaluative quality of life instruments which use a 7-point scale, is similar across individual domains and for both improvement and deterioration. Thirty nine adults with asthma were studied, using an 8 week cohort with assessments at 0, 4 and 8 weeks. The outcomes were the Asthma Quality of Life Questionnaire and global rating of change. For overall asthma-specific quality of life and for all individual domains (activities, emotions, symptoms), the minimal important difference of quality of life score per item was very close to 0.5 (range: 0.42-0.58); differences of approximately 1.0 represented a moderate change (range: 0.77-1.51); differences greater than 1.5 represented large changes. Changes for improvement and deterioration were very similar. The changes in quality of life score that represent a minimal important difference are very similar to those observed for other evaluative instruments. The observation that the minimal important difference is consistent across domains and for both improvement and deterioration will facilitate interpretation of results of studies examining quality of life.
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            Results of a home-based environmental intervention among urban children with asthma.

            Children with asthma who live in the inner city are exposed to multiple indoor allergens and environmental tobacco smoke in their homes. Reductions in these triggers of asthma have been difficult to achieve and have seldom been associated with decreased morbidity from asthma. The objective of this study was to determine whether an environmental intervention tailored to each child's allergic sensitization and environmental risk factors could improve asthma-related outcomes. We enrolled 937 children with atopic asthma (age, 5 to 11 years) in seven major U.S. cities in a randomized, controlled trial of an environmental intervention that lasted one year (intervention year) and included education and remediation for exposure to both allergens and environmental tobacco smoke. Home environmental exposures were assessed every six months, and asthma-related complications were assessed every two months during the intervention and for one year after the intervention. For every 2-week period, the intervention group had fewer days with symptoms than did the control group both during the intervention year (3.39 vs. 4.20 days, P<0.001) and the year afterward (2.62 vs. 3.21 days, P<0.001), as well as greater declines in the levels of allergens at home, such as Dermatophagoides farinae (Der f1) allergen in the bed (P<0.001) and on the bedroom floor (P=0.004), D. pteronyssinus in the bed (P=0.007), and cockroach allergen on the bedroom floor (P<0.001). Reductions in the levels of cockroach allergen and dust-mite allergen (Der f1) on the bedroom floor were significantly correlated with reduced complications of asthma (P<0.001). Among inner-city children with atopic asthma, an individualized, home-based, comprehensive environmental intervention decreases exposure to indoor allergens, including cockroach and dust-mite allergens, resulting in reduced asthma-associated morbidity. Copyright 2004 Massachusetts Medical Society
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              A new perspective on concepts of asthma severity and control.

              Concepts of asthma severity and control are important in the evaluation of patients and their response to treatment but the terminology is not standardised and the terms are often used interchangeably. This review, arising from the work of an American Thoracic Society/European Respiratory Society Task Force, identifies the need for separate concepts of control and severity, describes their evolution in asthma guidelines and provides a framework for understanding the relationship between current concepts of asthma phenotype, severity and control. "Asthma control" refers to the extent to which the manifestations of asthma have been reduced or removed by treatment. Its assessment should incorporate the dual components of current clinical control (e.g. symptoms, reliever use and lung function) and future risk (e.g. exacerbations and lung function decline). The most clinically useful concept of asthma severity is based on the intensity of treatment required to achieve good asthma control, i.e. severity is assessed during treatment. Severe asthma is defined as the requirement for (not necessarily just prescription or use of) high-intensity treatment. Asthma severity may be influenced by the underlying disease activity and by the patient's phenotype, both of which may be further described using pathological and physiological markers. These markers can also act as surrogate measures for future risk.
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                Author and article information

                Journal
                Thorax
                Thorax
                thorax
                thoraxjnl
                Thorax
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0040-6376
                1468-3296
                30 November 2011
                March 2012
                30 November 2011
                : 67
                : 3
                : 215-221
                Affiliations
                [1 ]Department of Paediatrics, Imperial College London, London, UK
                [2 ]Department of Woman and Child Health, Karolinska Institutet, Stockholm, Sweden
                [3 ]Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
                [4 ]Sachs' Children's Hospital, Stockholm, Sweden
                [5 ]Department of Respiratory Medicine and Allergology, Lund University Hospital, Lund, Sweden
                [6 ]Terveystalo Allergy Clinic, Turku, Finland
                [7 ]Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark
                [8 ]Research Institute for Prevention of Childrens' Allergy and Respiratory Diseases, Marien-Hospital, Wesel, Germany
                [9 ]Allergy Centre, University Hospital of Linköping, Linkoping, Sweden
                Author notes
                Correspondence to Professor John O Warner, Professor of Paediatrics, Imperial College London, Wright Fleming Building, Norfolk Place, London W2 1PG, UK; j.o.warner@ 123456imperial.ac.uk

                Trial Steering Committee Professor Olof Zetterström (Chair), University Hospital of Linköping, Sweden; Professor Leif Bjermer, Lund University Hospital, Sweden; Professor Ronald Dahl, Aarhus University Hospital, Denmark; Professor Erkka Valovirta, Terveystalo Turku, Finland; Dr Andrea Von Berg, Marien Hospital, Germany; Professor John Warner, Imperial College London, UK; Professor Magnus Wickman, Sachs' Children's Hospital, Stockholm, Sweden.

                Data and Safety Monitoring Committee Professor Jan Lötvall (Chair), Göteborg University, Sweden; Professor Stephen Durham, National Heart and Lung Institute, Imperial College London, UK; Fredrik Hansson, Commitum AB.

                [*]

                4A Study Group Members Robert Boyle, NIHR Biomedical Research Centre, Imperial College Healthcare NHS Trust and Imperial College London, UK; Christophe Pedroletti, Päivi Söderman and Björn Nordlund, Karolinska University Hospital Solna, Sweden; Per Tunqvist and Magnus Wickman, Sach's Children's Hospital, Sweden; Victoria Strand and Pär Gyllfors, Capio St Görans Hospital, Sweden; Janne Björkander, County Hospital Ryhov, Sweden; Leif Bjermer and Stefan Willers, Lund University Hospital, Sweden; Ann Hammarlund, Hospital of Ängelholm, Sweden; Bill Hesselmar and Nils Åberg, The Queen Silvia Children's Hospital, Sweden; Erkka Valovirta and and Heikki Valkama, Terveystalo Turku, Finland; Kai-Håkon Carlsen, Karin Lødrup Carlsen and Egil Bakkeheim, Ullevål University Hospital, Norway; Malcolm Sue-Chu, Trondheim University Hospital, Norway; Ronald Dahl, Aarhus University Hospital, Denmark; Vibecke Backer and Lotte Harmsen, Bispebjerg Hospital, Denmark; Claudia Gore, and Heather Hanna, Imperial College London, UK; Christian Virchow and Peter Julius, University of Rostock, Germany; Erika Von Mutius and Caroline von Ehrenstein, University of Munich, Germany; Andrea Von Berg and Christina Beckman, Marien-Hospital Wesel, Germany; Per Olof Wernersson, Allergimottagningen Karlstad, Sweden; Uwe Schauer, St Josef-Hospital Bochum, Germany; Olof Zetterström and Ulla Nyström Kronander, University Hospital of Linköping, Sweden; John Warner, NIHR Biomedical Research Centre, Imperial College Healthcare NHS Trust, and Imperial College London, UK.

                Article
                thoraxjnl-2011-200665
                10.1136/thoraxjnl-2011-200665
                3282042
                22131290
                f297a359-a5ab-4236-a0e6-b253151a34ac
                © 2012, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 22 June 2011
                : 11 October 2011
                Categories
                Asthma and the Environment
                1506
                1612
                Original article
                Custom metadata
                press-release

                Surgery
                aspergillus lung disease,allergic lung disease,paediatric asthma,quality of life,paediatric physician,exposure control,asthma pharmacology,temperature controlled laminar air flow,asthma,copd mechanisms,protexo,eosinophil biology

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