Marek Jutel1,2, Michael Rudert3, Fabian Kreimendahl3, Piotr Kuna4. 1. "ALL-MED" Medical Research Institute, Wroclaw, Poland. 2. Department of Clinical Immunology, Silesian Piasts University of Medicine, Wroclaw, Poland. 3. Allergopharma GmbH & Co. KG, Medical Department, Reinbek, Germany. 4. Barlicki University Hospital, Medical University, Lodz, Poland.
Abstract
AIM: This multicenter randomized placebo-controlled double-blind clinical trial investigated which maintenance dose shows the optimal benefit-risk ratio for subcutaneous immunotherapy with a Dermatophagoides pteronyssinus allergoid preparation. OBJECTIVE: To evaluate four maintenance doses of the allergoid preparation versus placebo. METHODS: The late-phase reaction of the intracutaneous test was chosen as efficacy parameter and minimal dose of fluticasone required for asthma control. RESULTS: A total of 146 adults with bronchial asthma were randomized. After subcutaneous immunotherapy, reductions in swelling size were greatest with 10,000 therapeutic units (TU). The 18,000 TU group showed the highest percentage of patients with fluticasone dose reduced to 0 μg/day. CONCLUSION: The optimal dose of allergoid for the investigation in a confirmatory trial with inhaled corticosteroid reduction is 18,000 TU.
RCT Entities:
AIM: This multicenter randomized placebo-controlled double-blind clinical trial investigated which maintenance dose shows the optimal benefit-risk ratio for subcutaneous immunotherapy with a Dermatophagoides pteronyssinus allergoid preparation. OBJECTIVE: To evaluate four maintenance doses of the allergoid preparation versus placebo. METHODS: The late-phase reaction of the intracutaneous test was chosen as efficacy parameter and minimal dose of fluticasone required for asthma control. RESULTS: A total of 146 adults with bronchial asthma were randomized. After subcutaneous immunotherapy, reductions in swelling size were greatest with 10,000 therapeutic units (TU). The 18,000 TU group showed the highest percentage of patients with fluticasone dose reduced to 0 μg/day. CONCLUSION: The optimal dose of allergoid for the investigation in a confirmatory trial with inhaled corticosteroid reduction is 18,000 TU.
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
Authors: Isabella Anna Joubert; Mark Geppert; Litty Johnson; Robert Mills-Goodlet; Sara Michelini; Evgeniia Korotchenko; Albert Duschl; Richard Weiss; Jutta Horejs-Höck; Martin Himly Journal: Front Immunol Date: 2020-06-30 Impact factor: 7.561
Authors: Gandhi F Pavón-Romero; Maria Itzel Parra-Vargas; Fernando Ramírez-Jiménez; Esmeralda Melgoza-Ruiz; Nancy H Serrano-Pérez; Luis M Teran Journal: Cells Date: 2022-01-08 Impact factor: 6.600