Subcutaneous allergen immunotherapy for asthma: A randomized, double-blind, placebo-controlled study with a standardized Blomia tropicalis vaccine
Raúl Lázaro Castro-Almarales, Mercedes Ronquillo-Díaz, Mirta Álvarez Castelló, José Severino Rodríguez-Canosa, Mayda González-León, Irene Enríquez-Domínguez, Bárbara Ivonne Navarro-Viltre, Maytee Mateo, Yunia Oliva-Díaz, Wendy Ramírez-González, Linda Cox, Alexis Labrada
Abstract
BACKGROUND: can be a therapeutic option, however, placebo-controlled clinical trials have not been reported. OBJECTIVE: by subcutaneous route, in allergic asthmatic patients exposed and sensitized to this mite species. METHODS: . AIT was administered subcutaneously in increasing doses from 4 to 6000 Biological Units using a locally manufactured standardized extract (BIOCEN, Cuba). Patient assessment was performed using symptom-medication score (SMS), peak expiratory flow and skin reactivity relative to Histamine as measured by skin prick test (SPT). RESULTS: . The change of specific skin reactivity was significantly (p < 0.05) correlated to clinical improvement. All adverse events were local with a frequency of 2.4% of injections. CONCLUSIONS: was effective and safe in asthmatic adults exposed and sensitized to this mite species in a tropical environment. TRIAL REGISTRATION: Cuban Public Registry of Clinical Trials: RPCEC00000026 (WHO International Clinical Trial Registry Platform ICTRP).