BACKGROUND: Although the efficacy of allergen immunotherapy has been demonstrated in seasonal pollen allergy, there is no report of a double-blind placebo-controlled trial with standardized pollen extract in seasonal respiratory allergy from India. In the agricultural area of eastern India, Phoenix sylvestris Roxb or date sugar palm is grown or cultivated and seasonal allergic rhinitis is common during the pollen season. OBJECTIVE: The objective of the present study was to observe the clinical and immunological changes during a 2-year double-blind placebo-controlled trial of immunotherapy with standardized P sylvestris pollen extract in respiratory patients sensitive to pollen from this wild date palm. Thirty-five subjects with typical seasonal allergic rhinitis with or without bronchial asthma were selected. A symptom-medication score (based on a questionnaire and diary) was correlated with pollen counts as recorded in a Burkard sampler. Eighteen subjects were randomized to a specific immunotherapy (SIT) group receiving regular injections containing standardized allergen extract and 17 to a placebo control group. Changes in the level of specific immunoglobulin (Ig) E, IgG1, and IgG4 were recorded at 3-month intervals. Measurement of wheal diameter, total IgE level and forced expiratory volume in 1 second (FEV1) were performed before starting and a month after finishing therapy. RESULTS: The SIT group showed decreases of 33.5% and 57% from the baseline symptom-medication scores during the first and second treatment season, respectively. This group showed significant decreases in skin-reactivity to P sylvestris pollen extract and in specific IgE levels, and significant increases in FEV,, specific IgGI (1.95-3.2 times higher) and IgG4 (21.24-30.83 times higher). There were no significant changes in total IgE levels. The control group showed no significant changes for any parameter except the development of new sensitization in 2 cases (to Saccharum officinarum pollen grain and Alternaria species spores). The rate of local adverse reactions was 0.024%. CONCLUSION: After a 2-year study, allergen immunotherapy with standardized P sylvestris pollen extract was found to be effective in seasonal respiratory allergic subjects susceptible to P sylvestris pollen with a narrow range of sensitization.
RCT Entities:
BACKGROUND: Although the efficacy of allergen immunotherapy has been demonstrated in seasonal pollen allergy, there is no report of a double-blind placebo-controlled trial with standardized pollen extract in seasonal respiratory allergy from India. In the agricultural area of eastern India, Phoenix sylvestrisRoxb or date sugar palm is grown or cultivated and seasonal allergic rhinitis is common during the pollen season. OBJECTIVE: The objective of the present study was to observe the clinical and immunological changes during a 2-year double-blind placebo-controlled trial of immunotherapy with standardized P sylvestris pollen extract in respiratory patients sensitive to pollen from this wild date palm. Thirty-five subjects with typical seasonal allergic rhinitis with or without bronchial asthma were selected. A symptom-medication score (based on a questionnaire and diary) was correlated with pollen counts as recorded in a Burkard sampler. Eighteen subjects were randomized to a specific immunotherapy (SIT) group receiving regular injections containing standardized allergen extract and 17 to a placebo control group. Changes in the level of specific immunoglobulin (Ig) E, IgG1, and IgG4 were recorded at 3-month intervals. Measurement of wheal diameter, total IgE level and forced expiratory volume in 1 second (FEV1) were performed before starting and a month after finishing therapy. RESULTS: The SIT group showed decreases of 33.5% and 57% from the baseline symptom-medication scores during the first and second treatment season, respectively. This group showed significant decreases in skin-reactivity to P sylvestris pollen extract and in specific IgE levels, and significant increases in FEV,, specific IgGI (1.95-3.2 times higher) and IgG4 (21.24-30.83 times higher). There were no significant changes in total IgE levels. The control group showed no significant changes for any parameter except the development of new sensitization in 2 cases (to Saccharum officinarum pollen grain and Alternaria species spores). The rate of local adverse reactions was 0.024%. CONCLUSION: After a 2-year study, allergen immunotherapy with standardized P sylvestris pollen extract was found to be effective in seasonal respiratory allergic subjects susceptible to P sylvestris pollen with a narrow range of sensitization.
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