BACKGROUND:Specific immunotherapy (SIT) is a valuable treatment for respiratory allergy, and the use of chemically modified allergens (allergoids) has improved its safety, as testified by several studies. We evaluated the effects of a SIT course with an allergoid extract of Parietaria pollen in a double-blind, placebo-controlled trial. METHODS: The study was double-blind in the first year; then it was prolonged up to 3 years with all patients on active treatment. Clinical effectiveness, safety, skin reactivity, systemic immunologic parameters, and subjective assessment were evaluated. We also had available a self-evaluation recorded in a follow-up visit 4 years after the discontinuation of SIT. RESULTS: A significant reduction of the symptoms plus drug intake scores during the pollen seasons was observed in the patients receiving active SIT. The placebo patients, after switching to active SIT, also showed significant clinical improvement. The clinical efficacy persisted during years 2 and 3 of treatment. After year 1, the actively treated patients reported a significant subjective improvement (frequency of symptoms, P = 0.001; duration of symptoms, P = 0.024; physical performance, P = 0.043) compared with the placebo group. The self-evaluation by visual analog scale showed that all patients maintained a significant clinical improvement up to 4 years after discontinuing SIT (year 1: active=+31.6%, placebo=-15.7%; year 7: active=+35.8%, placebo=+31.3%). The systemic immunologic changes after active SIT paralleled those described elsewhere (IgE decreased from 22 to 9 and from 21 to 8 IU/ml; IgG4 increased from 43 to 87 and from 18 to 60 IU/ml). A significant decrease in skin reactivity to three different allergen concentrations was observed at year 3 compared with pretreatment values (P<0.05). CONCLUSIONS: The investigational SIT with Parietaria appeared to be effective and safe; a 3-year course of treatment achieved a long-lasting efficacy.
RCT Entities:
BACKGROUND: Specific immunotherapy (SIT) is a valuable treatment for respiratory allergy, and the use of chemically modified allergens (allergoids) has improved its safety, as testified by several studies. We evaluated the effects of a SIT course with an allergoid extract of Parietaria pollen in a double-blind, placebo-controlled trial. METHODS: The study was double-blind in the first year; then it was prolonged up to 3 years with all patients on active treatment. Clinical effectiveness, safety, skin reactivity, systemic immunologic parameters, and subjective assessment were evaluated. We also had available a self-evaluation recorded in a follow-up visit 4 years after the discontinuation of SIT. RESULTS: A significant reduction of the symptoms plus drug intake scores during the pollen seasons was observed in the patients receiving active SIT. The placebo patients, after switching to active SIT, also showed significant clinical improvement. The clinical efficacy persisted during years 2 and 3 of treatment. After year 1, the actively treated patients reported a significant subjective improvement (frequency of symptoms, P = 0.001; duration of symptoms, P = 0.024; physical performance, P = 0.043) compared with the placebo group. The self-evaluation by visual analog scale showed that all patients maintained a significant clinical improvement up to 4 years after discontinuing SIT (year 1: active=+31.6%, placebo=-15.7%; year 7: active=+35.8%, placebo=+31.3%). The systemic immunologic changes after active SIT paralleled those described elsewhere (IgE decreased from 22 to 9 and from 21 to 8 IU/ml; IgG4 increased from 43 to 87 and from 18 to 60 IU/ml). A significant decrease in skin reactivity to three different allergen concentrations was observed at year 3 compared with pretreatment values (P<0.05). CONCLUSIONS: The investigational SIT with Parietaria appeared to be effective and safe; a 3-year course of treatment achieved a long-lasting efficacy.
Authors: Zsolt Szépfalusi; Waltraud Emminger; Franz Eitelberger; Manfred Götz; Andrea Grillenberger; Elisabeth Horak; Isidor Huttegger; Dieter Koller; Helmut Litscher; Rudolf Schmitzberger; Eva-Maria Varga; Josef Riedler Journal: Wien Klin Wochenschr Date: 2009 Impact factor: 1.704
Authors: Oliver Pfaar; Tobias Ankermann; Matthias Augustin; Petra Bubel; Sebastian Böing; Randolf Brehler; Peter A Eng; Peter J Fischer; Michael Gerstlauer; Eckard Hamelmann; Thilo Jakob; Jörg Kleine-Tebbe; Matthias Volkmar Kopp; Susanne Lau; Norbert Mülleneisen; Christoph Müller; Katja Nemat; Wolfgang Pfützner; Joachim Saloga; Klaus Strömer; Peter Schmid-Grendelmeier; Antje Schuster; Gunter Johannes Sturm; Christian Taube; Zsolt Szépfalusi; Christian Vogelberg; Martin Wagenmann; Wolfgang Wehrmann; Thomas Werfel; Stefan Wöhrl; Margitta Worm; Bettina Wedi; Susanne Kaul; Vera Mahler; Anja Schwalfenberg Journal: Allergol Select Date: 2022-09-06