BACKGROUND: The inhalation of Salsola kali pollen is a common cause of respiratory diseases in Europe and North America. OBJECTIVE: To evaluate the efficacy and safety of a depigmented and glutaraldehyde-polymerized therapeutic vaccine of S kali. METHODS: The trial was randomized, double-blind, and placebo-controlled using a rush protocol in the build-up phase. Sixty patients with rhinoconjunctivitis (19 also had mild asthma) were randomly allocated to receive either active treatment (polymerized extract) or placebo. The final distribution was 41 patients in the active and 19 in the placebo group. Side effects were registered. Symptom and medication scores and the number of days free of symptoms during the pollen season were assessed to evaluate the clinical efficacy. A Rhinoconjunctivitis Quality of Life Questionnaire was completed in the previous pollen season (before treatment) and during the pollen season 1 year later (in the trial). Dose-response skin tests were performed at baseline and at the end of the trial. RESULTS: There was a significant difference (P < .05) in symptom and medication scores between both groups during the pollen season, with the active group the one that had fewer symptoms and lower intake of medication. The number of days without symptoms was higher in the active group (P < .05). This group also had a significant improvement in the Rhinoconjunctivitis Quality of Life Questionnaire and a reduction in skin sensitivity. No moderate or severe systemic reactions were registered. CONCLUSION:Immunotherapy with this modified vaccine of S kali pollen is safe and efficacious to treat patients clinically sensitive to this pollen. CLINICAL IMPLICATIONS: Patients allergic to S kali (Russian thistle) can be successfully treated with immunotherapy to improve symptoms of allergic rhinitis and asthma, reduce medication use, and improve quality of life parameters.
RCT Entities:
BACKGROUND: The inhalation of Salsola kali pollen is a common cause of respiratory diseases in Europe and North America. OBJECTIVE: To evaluate the efficacy and safety of a depigmented and glutaraldehyde-polymerized therapeutic vaccine of S kali. METHODS: The trial was randomized, double-blind, and placebo-controlled using a rush protocol in the build-up phase. Sixty patients with rhinoconjunctivitis (19 also had mild asthma) were randomly allocated to receive either active treatment (polymerized extract) or placebo. The final distribution was 41 patients in the active and 19 in the placebo group. Side effects were registered. Symptom and medication scores and the number of days free of symptoms during the pollen season were assessed to evaluate the clinical efficacy. A Rhinoconjunctivitis Quality of Life Questionnaire was completed in the previous pollen season (before treatment) and during the pollen season 1 year later (in the trial). Dose-response skin tests were performed at baseline and at the end of the trial. RESULTS: There was a significant difference (P < .05) in symptom and medication scores between both groups during the pollen season, with the active group the one that had fewer symptoms and lower intake of medication. The number of days without symptoms was higher in the active group (P < .05). This group also had a significant improvement in the Rhinoconjunctivitis Quality of Life Questionnaire and a reduction in skin sensitivity. No moderate or severe systemic reactions were registered. CONCLUSION: Immunotherapy with this modified vaccine of S kali pollen is safe and efficacious to treat patients clinically sensitive to this pollen. CLINICAL IMPLICATIONS: Patientsallergic to S kali (Russian thistle) can be successfully treated with immunotherapy to improve symptoms of allergic rhinitis and asthma, reduce medication use, and improve quality of life parameters.
Authors: Sarah K Wise; Sandra Y Lin; Elina Toskala; Richard R Orlandi; Cezmi A Akdis; Jeremiah A Alt; Antoine Azar; Fuad M Baroody; Claus Bachert; G Walter Canonica; Thomas Chacko; Cemal Cingi; Giorgio Ciprandi; Jacquelynne Corey; Linda S Cox; Peter Socrates Creticos; Adnan Custovic; Cecelia Damask; Adam DeConde; John M DelGaudio; Charles S Ebert; Jean Anderson Eloy; Carrie E Flanagan; Wytske J Fokkens; Christine Franzese; Jan Gosepath; Ashleigh Halderman; Robert G Hamilton; Hans Jürgen Hoffman; Jens M Hohlfeld; Steven M Houser; Peter H Hwang; Cristoforo Incorvaia; Deborah Jarvis; Ayesha N Khalid; Maritta Kilpeläinen; Todd T Kingdom; Helene Krouse; Desiree Larenas-Linnemann; Adrienne M Laury; Stella E Lee; Joshua M Levy; Amber U Luong; Bradley F Marple; Edward D McCoul; K Christopher McMains; Erik Melén; James W Mims; Gianna Moscato; Joaquim Mullol; Harold S Nelson; Monica Patadia; Ruby Pawankar; Oliver Pfaar; Michael P Platt; William Reisacher; Carmen Rondón; Luke Rudmik; Matthew Ryan; Joaquin Sastre; Rodney J Schlosser; Russell A Settipane; Hemant P Sharma; Aziz Sheikh; Timothy L Smith; Pongsakorn Tantilipikorn; Jody R Tversky; Maria C Veling; De Yun Wang; Marit Westman; Magnus Wickman; Mark Zacharek Journal: Int Forum Allergy Rhinol Date: 2018-02 Impact factor: 3.858
Authors: M Angeles López-Matas; Mayte Gallego; Víctor Iraola; Douglas Robinson; Jerónimo Carnés Journal: Biomed Res Int Date: 2013-10-08 Impact factor: 3.411