Sublingual immunotherapy.
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Biomedical subjects
Publications and source records attributed to Karl-Christian Bergmann.
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QUESTIONS UNDER STUDY: if patients with asthma remain symptomatic in spite of chronic treatment with inhaled corticosteroids (ICS), increasing the ICS dosage or adding another drug to the treatment regimen are possible therapeutic alternatives. We compared the efficacy and safety of combined salmeterol fluticasone therapy (SFC, 50/250 microg twice daily) with twice the dose of fluticasone propionate (FP, 500 microg b.i.d.) in symptomatic asthmatics. METHODS: this prospective, double-blind study was conducted in 76 study centres. 365 symptomatic patients with moderate asthma aged >18 years and receiving ICS in a dose equivalent to 1000 microg beclomethasone propionate per day were randomly assigned to receive either salmeterol xinafoate (50 microg) and fluticasone propionate (250 microg) in a single dry powder inhaler (Diskus) or 500 microg FP twice daily. The primary efficacy endpoint was morning peak expiratory flow rate (PEFR). Secondary measurements included forced expiratory volume in 1 second (FEV1), asthma symptom scores, and use of rescue medication. RESULTS: combined salmeterol fluticasone therapy resulted in significantly greater improvements in PEFR and symptom control than doubling the dose of FP. At week 12, morning PEFR had increased by 52 L/min from baseline in patients on SFC and by 36 L/min in subjects receiving FP. The adjusted difference between groups was 16.6 L/min (95% confidence interval, 1.1 to 32.0 L/min). In the SFC group, the percentage of symptom-free days increased from baseline by 49% of days as compared with 38% of days after FP (adjusted difference: 12.6% of days, 95% CI 4.0 to 20.7). Quality of life improved to a greater degree after SFC therapy, and patients regarded study drugs as superior to their previous asthma medication. Adverse event profiles were similar between groups. CONCLUSIONS: the combination of salmeterol 50 microg and fluticasone 250 microg in a single dry powder inhaler was superior to twice the dose of FP (500 microg). It seems justified to add salmeterol rather than increasing the ICS dose if symptomatic asthmatics require supplementary therapy.
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BACKGROUND: Specific immunotherapy (SIT) and treatment with monoclonal anti-IgE antibody have complementary modes of action. OBJECTIVE: The purpose of this study was to determine whether combined therapy could provide better efficacy than either treatment alone. METHODS: We conducted a randomized, double-blinded trial to assess the efficacy and safety of subcutaneously administered anti-IgE (omalizumab) or placebo in children and adolescents with seasonal allergic rhinitis in both a birch pollen season and a grass pollen season (sequential seasons together lasting an average of 84 days). There were 4 treatment arms. Each subject was started on SIT-birch or SIT-grass, and anti-IgE or placebo was started before and maintained during the anticipated pollen seasons (a total of 24 weeks). The primary efficacy variable was symptom load, the sum of daily symptom severity score plus rescue medication use. RESULTS: A total of 221 subjects (intent-to-treat population) aged 6 to 17 years were analyzed for efficacy. Combination therapy reduced symptom load over the 2 pollen seasons by 48% (P <.001) over SIT alone. When analyzed separately by season, the 2 groups receiving unrelated SIT were considered placebo controls. In the grass season, symptom loads were as follows: unrelated (birch) SIT + placebo, 0.89 (reference value); unrelated (birch) SIT + anti-IgE, 0.49 (-45%); SIT-grass + placebo, 0.61 (-32%); SIT-grass + anti-IgE, 0.26 (-71%). CONCLUSION: Anti-IgE therapy conferred a protective effect independent of the type of allergen. Additional clinical benefit was demonstrated in both pollen seasons, whether there was coverage by SIT or not. This combination might prove useful for the treatment of allergic rhinitis, particularly for polysensitized patients.
Sensitization to domestic mites is common in Germany. The main objectives of this study were (1) to establish the rate of skin test sensitivity to Dermatophagoides pteronyssinus, Acarus siro, Lepidoglyphus destructor, and Tyrophagus putrescentiae in 512 consecutive patients evaluated for upper and/or lower respiratory complaints; (2) to verify how many of the patients with a positive skin test to at least one of the three storage mites were also skin test positive to D. pteronyssinus; and (3) to verify how many of the patients with at least one positive skin test to one of the storage mites previously mentioned were also sensitized, in vitro, to other mite species. A total of 512 consecutive patients with rhinitis and/or asthma, living in urban or rural areas of central Germany were skin tested with extracts of D. pteronyssinus, A. siro, L. destructor, and T. putrescentiae. In addition, specific IgE determinations to Euroglyphus maynei, Blomia tropicalis, Blomia tjibodas, Blomia kulagini, and Gohieria fusca were conducted in those individuals with a positive skin test to at least one of the storage mites used in skin testing. Of the 512 patients, 103 (20.1%; 77 urban dwellers and 26 farmers) reacted to at least one of the storage mites. From this latter group, 88 individuals (85.4%) also skin tested positive to D. pteronyssinus. In vitro specific IgE determinations revealed a high rate of sensitization to the other mite species studied. We conclude that sensitization to storage mites in Germany is frequently associated with sensitivity to D. pteronyssinus. Overall, skin test sensitivity to storage mites was greater in rural than in city dwellers. In vitro sensitization to B. tjibodas was also significantly greater in rural than in city dwellers.