BACKGROUND: First reports on sublingual immunotherapy were published in 1980. OBJECTIVE: To compare safety and effectiveness of sublingual immunotherapy, as compared with placebo, in asthmatic patients. MATERIALS: In a blinded randomized controlled trial asthmatic patients with positive skin prick tests to Dermatophagoides pteronyssinus, and with serum IgE at least 200 UI were included. According to GINA, asthma severity was mild persistent and moderate. All patients improved their baseline FEV1 at least by 14% after inhaled albuterol. Spirometry was performed again after three and six months after initiating treatment. Patients were randomized to receive for six months either sublingual immunotherapy with Der p 1 standardized allergens (IPI-ASAC, México) at a total dose of 10,469 UBE or identically looking and tasting placebo. Both groups received conventional pharmacological therapy. RESULTS:Sixty four patients enter the study; four were excluded because of systemic oral steroid therapy. Sixty patients underwent randomization. Both groups (30 patients in each one) were similar in their baseline characteristics. After six months, patients that received sublingual immunotherapy had less exacerbations than those in the control group (61 vs 123, T 2.61, p<0.001, IC 1.8-7.2), better FEV1 as compared with baseline values (25% vs 9%, Z=0.66, p=0.03), and less need of albuterol (50% of initial dose, vs 21% (Z=1.4, p=0.03, IC 1.39-1.49). CONCLUSION:Sublingual immunotherapy improves patient symptoms and pulmonary functional tests, makes exacerbations less frequent, and reduces albuterol needs. It may improve asthma related quality of life.
RCT Entities:
BACKGROUND: First reports on sublingual immunotherapy were published in 1980. OBJECTIVE: To compare safety and effectiveness of sublingual immunotherapy, as compared with placebo, in asthmatic patients. MATERIALS: In a blinded randomized controlled trial asthmatic patients with positive skin prick tests to Dermatophagoides pteronyssinus, and with serum IgE at least 200 UI were included. According to GINA, asthma severity was mild persistent and moderate. All patients improved their baseline FEV1 at least by 14% after inhaled albuterol. Spirometry was performed again after three and six months after initiating treatment. Patients were randomized to receive for six months either sublingual immunotherapy with Der p 1 standardized allergens (IPI-ASAC, México) at a total dose of 10,469 UBE or identically looking and tasting placebo. Both groups received conventional pharmacological therapy. RESULTS: Sixty four patients enter the study; four were excluded because of systemic oral steroid therapy. Sixty patients underwent randomization. Both groups (30 patients in each one) were similar in their baseline characteristics. After six months, patients that received sublingual immunotherapy had less exacerbations than those in the control group (61 vs 123, T 2.61, p<0.001, IC 1.8-7.2), better FEV1 as compared with baseline values (25% vs 9%, Z=0.66, p=0.03), and less need of albuterol (50% of initial dose, vs 21% (Z=1.4, p=0.03, IC 1.39-1.49). CONCLUSION: Sublingual immunotherapy improves patient symptoms and pulmonary functional tests, makes exacerbations less frequent, and reduces albuterol needs. It may improve asthma related quality of life.
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