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  • 1
    Language: English
    In: Respiratory Medicine, May 2015, Vol.109(5), pp.616-624
    Description: The inhaled long-acting muscarinic antagonist aclidinium bromide has been shown to significantly improve lung function parameters and symptom severity in patients with COPD in randomised placebo- and active-controlled clinical studies. To obtain a comprehensive view of the treatment effects, patient-reported outcomes were investigated in a real-life COPD population in routine clinical practice in Austria. Multicentre, prospective, non-interventional study in patients with COPD who were newly initiated on treatment with Eklira Genuair (aclidinium bromide; recommended dose 400 μg twice daily) as first-line or add-on therapy. Patients were either treatment naïve or switched from other COPD medications. Health-related quality of life by means of the COPD Assessment Test™ (CAT) and symptom-related variables were evaluated at the first visit (baseline) and after approximately 12 weeks of treatment. Features of the inhaler were assessed by patients and physicians at the follow-up visit. A total of 795 COPD patients (56% male; median age: 64 years) were enrolled and treated. During the observational period, the proportion of patients with at least moderate nighttime symptoms, early-morning symptoms, and limitations in morning activities decreased from 45.0% to 21.4%, from 57.7% to 26.0%, and from 49.9% to 25.3%, respectively. All improvements from baseline in symptom severity and activity limitation were statistically significant (p 〈 0.0001, all tests). The mean (±SD) frequency of nocturnal awakenings decreased from 1.2 (±1.4) to 0.7 (±1.2) times per night (p 〈 0.0001). Quality of life improved significantly in patients treated with aclidinium bromide over 3 months compared to baseline (p 〈 0.0001; mean CAT total score: 18.5 ± 7.5 vs. 13.8 ± 7.3). Up to 90% of the patients and up to 91% of the physicians assessed individual features of the inhaler as ‘very good’ or ‘good’. Aclidinium bromide was well tolerated; 6.9% of the patients reported adverse drug reactions, none of which were serious. This non-interventional study indicated beneficial effects of Eklira Genuair in the treatment of COPD with regard to nighttime and early-morning symptoms, limitation of morning activities, and quality of life under routine conditions. The acceptance of the inhaler device was high, which is a prerequisite to ensure adherence in long-term therapy.
    Keywords: Aclidinium Bromide ; Copd ; Morning Symptoms ; Quality of Life ; Non-Interventional Study ; Medicine
    ISSN: 0954-6111
    E-ISSN: 1532-3064
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  • 2
    Language: English
    In: The Journal of Allergy and Clinical Immunology, December 2012, Vol.130(6), pp.1418-1420.e4
    Description: To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.jaci.2012.06.028 Byline: Christian Lupinek (a), Katharina Marth (a)(b), Verena Niederberger (c), Rudolf Valenta (a)(b) Author Affiliation: (a) Division of Immunopathology, Department of Pathophysiology and Allergy Research, Centre for Pathophysiology, Infectiology & Immunology, Medical University of Vienna, Vienna, Austria (b) Christian Doppler Laboratory for Allergy Research, Division of Immunopathology, Department of Pathophysiology and Allergy Research, Centre for Pathophysiology, Infectiology & Immunology, Medical University of Vienna, Vienna, Austria (c) Department of Otorhinolaryngology, Medical University of Vienna, Vienna, Austria Article Note: (footnote) Supported by grants F4605 and F4613 of the Austrian Science Fund (FWF), and research grants from Phadia, Uppsala, Sweden, and Biomay, Vienna, Austria; the Christian Doppler Research Association; and in part by the European Commission's Seventh Framework Programme under grant agreement 261357., Disclosure of potential conflict of interest: V. Niederberger and R. Valenta have received research support from the FWF Austrian Science Fund. The rest of the authors declare that they have no relevant conflicts of interest.
    Keywords: Medicine
    ISSN: 0091-6749
    E-ISSN: 1097-6825
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  • 3
    Language: English
    In: PLoS ONE, 01 January 2014, Vol.9(6), p.e97893
    Description: The infection of CD4+ cells by HIV leads to the progressive destruction of CD4+ T lymphocytes and, after a severe reduction of CD4+ cells, to AIDS. The aim of the study was to investigate whether HIV-infected patients with CD4 cell counts 〈200 cells/µl can suffer from symptoms of IgE-mediated allergy, produce allergen-specific IgE antibody responses and show boosts of allergen-specific IgE production. HIV-infected patients with CD4 counts ≤ 200 cells/µl suffering from AIDS and from IgE-mediated allergy were studied. Allergy was diagnosed according to case history, physical examination, skin prick testing (SPT), and serological analyses including allergen microarrays. HIV infection was confirmed serologically and the disease was staged clinically. The predominant allergic symptoms in the studied patients were acute allergic rhinitis (73%) followed by asthma (27%) due to IgE-mediated mast cell activation whereas no late phase allergic symptoms such as atopic dermatitis, a mainly T cell-mediated skin manifestation, were found in patients suffering from AIDS. According to IgE serology allergies to house dust mites and grass pollen were most common besides IgE sensitizations to various food allergens. Interestingly, pollen allergen-specific IgE antibody levels in the patients with AIDS and in additional ten IgE-sensitized patients with HIV infections and low CD4 counts appeared to be boosted by seasonal allergen exposure and were not associated with CD4 counts. Our results indicate that secondary allergen-specific IgE production and IgE-mediated allergic inflammation do not require a fully functional CD4+ T lymphocyte repertoire.
    Keywords: Sciences (General)
    E-ISSN: 1932-6203
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  • 4
    Language: English
    In: PLoS ONE, June 4, 2014, Vol.9(6)
    Description: The infection of CD4+ cells by HIV leads to the progressive destruction of CD4+ T lymphocytes and, after a severe reduction of CD4+ cells, to AIDS. The aim of the study was to investigate whether HIV-infected patients with CD4 cell counts 200 cells/[micro]l can suffer from symptoms of IgE-mediated allergy, produce allergen-specific IgE antibody responses and show boosts of allergen-specific IgE production. HIV-infected patients with CD4 counts [less than or equal to]200 cells/[micro]l suffering from AIDS and from IgE-mediated allergy were studied. Allergy was diagnosed according to case history, physical examination, skin prick testing (SPT), and serological analyses including allergen microarrays. HIV infection was confirmed serologically and the disease was staged clinically. The predominant allergic symptoms in the studied patients were acute allergic rhinitis (73%) followed by asthma (27%) due to IgE-mediated mast cell activation whereas no late phase allergic symptoms such as atopic dermatitis, a mainly T cell-mediated skin manifestation, were found in patients suffering from AIDS. According to IgE serology allergies to house dust mites and grass pollen were most common besides IgE sensitizations to various food allergens. Interestingly, pollen allergen-specific IgE antibody levels in the patients with AIDS and in additional ten IgE-sensitized patients with HIV infections and low CD4 counts appeared to be boosted by seasonal allergen exposure and were not associated with CD4 counts. Our results indicate that secondary allergen-specific IgE production and IgE-mediated allergic inflammation do not require a fully functional CD4+ T lymphocyte repertoire.
    Keywords: T Cells – Analysis ; T Cells – Health Aspects ; AIDS (Disease) – Analysis ; AIDS (Disease) – Health Aspects ; HIV Patients – Analysis ; HIV Patients – Health Aspects ; B Cells – Analysis ; B Cells – Health Aspects ; Infection – Analysis ; Infection – Health Aspects ; Immunoglobulin E – Analysis ; Immunoglobulin E – Health Aspects ; Atopic Dermatitis – Analysis ; Atopic Dermatitis – Health Aspects ; Food Hypersensitivity – Analysis ; Food Hypersensitivity – Health Aspects ; Allergens – Analysis ; Allergens – Health Aspects
    ISSN: 1932-6203
    Source: Cengage Learning, Inc.
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  • 5
    Language: English
    In: The Journal of Allergy and Clinical Immunology, 2011, Vol.127(4), pp.860-864
    Description: This year we are celebrating not only the centenary of allergen-specific immunotherapy but also the 10-year anniversary of the first administration of recombinant allergen–based vaccines to allergic patients. By using recombinant DNA technology, defined and safe allergy vaccines can be produced that allow us to overcome many, if not all, of the problems associated with the use of natural allergen extracts, such as insufficient quality, allergenic activity, and poor immunogenicity. Here we provide an update of clinical studies with recombinant allergen–based vaccines, showing that some of these vaccines have undergone successful clinical evaluation up to phase III studies. Furthermore, we introduce a strategy for allergen-specific immunotherapy based on recombinant fusion proteins consisting of viral carrier proteins and allergen-derived peptides without allergenic activity, which holds the promise of being free of side effects and eventually being useful for prophylactic vaccination.
    Keywords: Allergy ; Allergen-Specific Immunotherapy ; Recombinant Allergen ; Medicine
    ISSN: 0091-6749
    E-ISSN: 1097-6825
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  • 6
    Language: English
    In: PLoS ONE, 2012, Vol.7(1), p.e29925
    Description: The phosphoinositide 3-kinase (PI3-kinase) and the mammalian target of rapamycin (mTOR) are two major signaling molecules involved in growth and activation of mast cells (MC) and basophils (BA). We examined the effects of the dual PI3-kinase/mTOR blocker NVP-BEZ235 on growth of normal and neoplastic BA and MC as well as immunoglobulin E (IgE)-dependent cell activation. Growth of MC and BA were determined by measuring 3 H-thymidine uptake and apoptosis. Cell activation was determined in histamine release experiments and by measuring upregulation of CD63 and CD203c after challenging with IgE plus anti-IgE or allergen. We found that NVP-BEZ235 exerts profound inhibitory effects on growth of primary and cloned neoplastic MC. In the MC leukemia cell line HMC-1, NVP-BEZ235 showed similar IC 50 values in the HMC-1.1 subclone lacking KIT D816V (0.025 µM) and the HMC-1.2 subclone expressing KIT D816V (0.005 µM). Moreover, NVP-BEZ235 was found to exert strong growth-inhibitory effects on neoplastic MC in a xenotransplant-mouse model employing NMR1-Foxn1 nu mice. NVP-BEZ235 also exerted inhibitory effects on cytokine-dependent differentiation of normal BA and MC, but did not induce growth inhibition or apoptosis in mature MC or normal bone marrow cells. Finally, NVP-BEZ235 was found to inhibit IgE-dependent histamine release in BA and MC (IC 50 0.5–1 µM) as well as anti-IgE-induced upregulation of CD203c in BA and IgE-dependent upregulation of CD63 in MC. In summary, NVP-BEZ235 produces growth-inhibitory effects in immature neoplastic MC and inhibits IgE-dependent activation of mature BA and MC. Whether these potentially beneficial drug effects have clinical implications is currently under investigation.
    Keywords: Research Article ; Biology ; Immunology ; Molecular Biology ; Cell Biology ; Developmental Biology
    E-ISSN: 1932-6203
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  • 7
    Language: English
    In: The Journal of Allergy and Clinical Immunology, October 2015, Vol.136(4), pp.1101-1103.e8
    Description: To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.jaci.2015.03.034 Byline: Verena Niederberger, Katharina Marth, Julia Eckl-Dorna, Margarete Focke-Tejkl, Milena Weber, Wolfgang Hemmer, Uwe Berger, Angela Neubauer, Frank Stolz, Rainer Henning, Rudolf Valenta Author Affiliation: (a) Department of Otorhinolaryngology, Medical University of Vienna, Vienna, Austria (b) Division of Immunopathology, Department of Pathophysiology and Allergy Research, Centre for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Vienna, Austria (c) FAZ - Floridsdorf Allergy Center, Vienna, Austria (d) Biomay AG, Vienna, Austria Article Note: (footnote) This study was funded by Biomay AG, Vienna, Austria, the Christian Doppler Laboratory for Allergy Research, by the SFB Program F46 of the Austrian Science Fund (FWF, grants nos. F4605 and F4613), and the Austrian Research Promotion Agency (grant nos. 830432 and 835415)., Disclosure of potential conflict of interest: V. Niederberger has received consultancy fees from Biomay AG, and her institution has recently received funding for other studies from Biomay AG. K. Marth has received payment for delivering lectures from Thermo Fisher. J. Eckl-Dorna's institution has received funding from the Austrian Science Fund (FWF). A. Neubauer, F. Stolz, and R. Henning are employees and shareholders of Biomay AG, which has received grants from the Austrian Research Promotion Agency (FFG; grant nos. 830432 and 835415) and receives royalties from Thermo Fisher. R. Valenta's institution has received funding from the FWF, Biomay AG, and Thermo Fisher; he has received consultancy fees from Biomay AG and Thermo Fisher. The rest of the authors declare that they have no relevant conflicts of interest.
    Keywords: Medicine
    ISSN: 0091-6749
    E-ISSN: 1097-6825
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  • 8
    Language: English
    In: The Journal of Allergy and Clinical Immunology, January 2017, Vol.139(1), pp.290-299.e4
    Description: Increasing evidence suggests that the low-affinity receptor for IgE, CD23, plays an important role in controlling the activity of allergen-specific T cells through IgE-facilitated allergen presentation. We sought to determine the number of CD23 molecules on immune cells in allergic patients and to investigate whether the number of CD23 molecules on antigen-presenting cells is associated with IgE levels and influences allergen uptake and allergen-specific T-cell activation. Numbers of CD23 molecules on immune cells of allergic patients were quantified by using flow cytometry with QuantiBRITE beads and compared with total and allergen-specific IgE levels, as well as with allergen-induced immediate skin reactivity. Allergen uptake and allergen-specific T-cell activation in relation to CD23 surface density were determined by using flow cytometry in combination with confocal microscopy and T cells transfected with the T-cell receptor specific for the birch pollen allergen Bet v 1, respectively. Defined IgE-allergen immune complexes were formed with human monoclonal allergen-specific IgE and Bet v 1. In allergic patients the vast majority of CD23 molecules were expressed on naive IgD B cells. The density of CD23 molecules on B cells but not the number of CD23 cells correlated with total IgE levels (  = 0.53,  = .03) and allergen-induced skin reactions (  = 0.63,  = .008). Uptake of allergen-IgE complexes into B cells and activation of allergen-specific T cells depended on IgE binding to CD23 and were associated with CD23 surface density. Addition of monoclonal IgE to cultured PBMCs significantly (  = .04) increased CD23 expression on B cells. CD23 surface density on B cells of allergic patients is correlated with allergen-specific IgE levels and determines allergen uptake and subsequent activation of T cells.
    Keywords: Cd23 ; Allergy ; Ige ; Low-Affinity Ige Receptor ; B cell ; Allergen ; Medicine
    ISSN: 0091-6749
    E-ISSN: 1097-6825
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  • 9
    Language: English
    In: The Journal of Allergy and Clinical Immunology, February 2016, Vol.137(2), pp.601-609.e8
    Description: Late allergic reactions are common in the course of allergen-specific immunotherapy and even occur with allergy vaccines with reduced IgE reactivity. We sought to study atopy patch test (APT) reactions and T-cell responses to the recombinant birch pollen allergen Bet v 1 and recombinant hypoallergenic T-cell epitope–containing Bet v 1 fragments in patients with birch pollen allergy with and without atopic dermatitis (AD). A clinical study was conducted in 15 patients with birch pollen allergy with AD (group 1), 5 patients with birch pollen allergy without AD (group 2), 5 allergic patients without birch pollen allergy (group 3), and 5 nonallergic subjects (group 4) by performing skin prick tests and APTs with rBet v 1 and hypoallergenic rBet v 1 fragments. T-cell, cutaneous lymphocyte antigen (CLA) and CCR4 T-cell and cytokine responses were studied by thymidine uptake, carboxyfluorescein diacetate succinimidyl ester staining, and Luminex technology, respectively. rBet v 1 and hypoallergenic rBet v 1 fragments induced APT reactions in not only most of the patients with birch pollen allergy with AD (11/15) but also in most of those without AD (4/5). Patients with birch pollen allergy with AD had higher Bet v 1–specific proliferation of CLA and CCR4 T cells compared with patients with birch pollen allergy without AD. There were no differences in Bet v 1–specific CLA and CCR4 proliferation and cytokine secretion in patients with and without APT reactions. Hypoallergenic rBet v 1 fragments induce T cell–dependent late reactions not only in patients with birch pollen allergy with AD but also in those without AD, which can be determined based on APT results but not based on parameters.
    Keywords: Allergy ; Allergen ; Recombinant Hypoallergens ; Atopy Patch Testing ; Late-Phase Reaction ; T-Cell Proliferation ; Cutaneous Lymphocyte Antigen ; Ccr4 ; Birch Pollen Allergy ; Rbet V 1 ; Rbet V 1 Fragments ; Specific Immunotherapy ; Medicine
    ISSN: 0091-6749
    E-ISSN: 1097-6825
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  • 10
    Language: English
    In: The Journal of Allergy and Clinical Immunology, May 2015, Vol.135(5), pp.1207-1217.e11
    Description: Grass pollen is one of the most important sources of respiratory allergies worldwide. This study describes the development of a grass pollen allergy vaccine based on recombinant hypoallergenic derivatives of the major timothy grass pollen allergens Phl p 1, Phl p 2, Phl p 5, and Phl p 6 by using a peptide-carrier approach. Fusion proteins consisting of nonallergenic peptides from the 4 major timothy grass pollen allergens and the PreS protein from hepatitis B virus as a carrier were expressed in and purified by means of chromatography. Recombinant PreS fusion proteins were tested for allergenic activity and T-cell activation by means of IgE serology, basophil activation testing, T-cell proliferation assays, and xMAP Luminex technology in patients with grass pollen allergy. Rabbits were immunized with PreS fusion proteins to characterize their immunogenicity. Ten hypoallergenic PreS fusion proteins were constructed, expressed, and purified. According to immunogenicity and induction of allergen-specific blocking IgG antibodies, 4 hypoallergenic fusion proteins (BM321, BM322, BM325, and BM326) representing Phl p 1, Phl p 2, Phl p 5, and Phl p 6 were included as components in the vaccine termed BM32. BM321, BM322, BM325, and BM326 showed almost completely abolished allergenic activity and induced significantly reduced T-cell proliferation and release of proinflammatory cytokines in patients' PBMCs compared with grass pollen allergens. On immunization, they induced allergen-specific IgG antibodies, which inhibited patients' IgE binding to all 4 major allergens of grass pollen, as well as allergen-induced basophil activation. A recombinant hypoallergenic grass pollen allergy vaccine (BM32) consisting of 4 recombinant PreS-fused grass pollen allergen peptides was developed for safe immunotherapy of grass pollen allergy.
    Keywords: Grass Pollen Allergy ; Allergen ; Recombinant Allergen ; Recombinant Hypoallergenic Allergen Derivative ; Allergen-Specific Immunotherapy ; Peptide-Carrier Technology ; Medicine
    ISSN: 0091-6749
    E-ISSN: 1097-6825
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