BACKGROUND: A randomized double-blind, placebo-controlled study was conducted in patients allergic asthma sensitized to Dermatophagoides pteronyssinus. OBJECTIVE: To evaluate the efficacy and safety after 1-year of immunotherapy with a modified D. pteronyssinus extract compared with placebo. MATERIAL AND METHODS:Fifty-five patients were randomly allocated to receive the active treatment (n = 29), or placebo (n = 26). The main outcome was the specific bronchial provocation test (BPT). Other parameters analysed were dose-response skin prick test (SPT), symptom and medication scores and asthma quality of life (AQLQ). RESULTS: At the end of the study, the active group showed a significant increase in the PD(20)FEV(1) compared with placebo (P = 0.0029). Nineteen patients of the active vs 10 of theplacebo group needed more than twice the initial amount of allergen extract to have a positive BPT (P = 0.0293); seven patients in the placebo vs one in the active group needed less than half (P = 0.0137). In SPT, a significant improvement (P = 0.0049) was found in the active group. This group also had a median reduction of 91.5% in symptom scores, whereas the placebo group increased by 86%. Medication scores decreased in both groups (56% in the active and 11.4% in the placebo). In AQLQ, the differences between both groups were significant (P = 0.0234) at the end of the study. CONCLUSION: After 1 year of treatment, the modified extract of D. pteronyssinus demonstrated to be safe and efficacious to treat patients with asthma and allergic rhinoconjunctivitis sensitized to this mite.
RCT Entities:
BACKGROUND: A randomized double-blind, placebo-controlled study was conducted in patientsallergic asthma sensitized to Dermatophagoides pteronyssinus. OBJECTIVE: To evaluate the efficacy and safety after 1-year of immunotherapy with a modified D. pteronyssinus extract compared with placebo. MATERIAL AND METHODS: Fifty-five patients were randomly allocated to receive the active treatment (n = 29), or placebo (n = 26). The main outcome was the specific bronchial provocation test (BPT). Other parameters analysed were dose-response skin prick test (SPT), symptom and medication scores and asthma quality of life (AQLQ). RESULTS: At the end of the study, the active group showed a significant increase in the PD(20)FEV(1) compared with placebo (P = 0.0029). Nineteen patients of the active vs 10 of the placebo group needed more than twice the initial amount of allergen extract to have a positive BPT (P = 0.0293); seven patients in the placebo vs one in the active group needed less than half (P = 0.0137). In SPT, a significant improvement (P = 0.0049) was found in the active group. This group also had a median reduction of 91.5% in symptom scores, whereas the placebo group increased by 86%. Medication scores decreased in both groups (56% in the active and 11.4% in the placebo). In AQLQ, the differences between both groups were significant (P = 0.0234) at the end of the study. CONCLUSION: After 1 year of treatment, the modified extract of D. pteronyssinus demonstrated to be safe and efficacious to treat patients with asthma and allergic rhinoconjunctivitis sensitized to this mite.
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: Michelle M Cloutier; Alan P Baptist; Kathryn V Blake; Edward G Brooks; Tyra Bryant-Stephens; Emily DiMango; Anne E Dixon; Kurtis S Elward; Tina Hartert; Jerry A Krishnan; Robert F Lemanske; Daniel R Ouellette; Wilson D Pace; Michael Schatz; Neil S Skolnik; James W Stout; Stephen J Teach; Craig A Umscheid; Colin G Walsh Journal: J Allergy Clin Immunol Date: 2020-12 Impact factor: 10.793
Authors: Oliver Pfaar; Claus Bachert; Albrecht Bufe; Roland Buhl; Christof Ebner; Peter Eng; Frank Friedrichs; Thomas Fuchs; Eckard Hamelmann; Doris Hartwig-Bade; Thomas Hering; Isidor Huttegger; Kirsten Jung; Ludger Klimek; Matthias Volkmar Kopp; Hans Merk; Uta Rabe; Joachim Saloga; Peter Schmid-Grendelmeier; Antje Schuster; Nicolaus Schwerk; Helmut Sitter; Ulrich Umpfenbach; Bettina Wedi; Stefan Wöhrl; Margitta Worm; Jörg Kleine-Tebbe; Susanne Kaul; Anja Schwalfenberg Journal: Allergo J Int Date: 2014