Background: Subcutaneous immunotherapy with high dose grass pollen (typically microgram quantities) was first\r\ndescribed over 100 years ago. This treatment suppresses allergen-induced cutaneous late responses, with lesser effects\r\non early responses. We previously reported that repeated 2-weekly intradermal injections of grass pollen - containing\r\napproximately 7 ng of major allergen Phl p 5 ââ?¬â?? led to a progressive suppression of the allergen-induced cutaneous\r\nresponse, and that by the sixth injection, this was inhibited by over 90%. The purpose of this trial is to investigate the\r\nclinical efficacy of intradermal desensitisation with low doses (i.e. nanogram quantities) of grass pollen allergen for\r\nseasonal allergic rhinitis.\r\nMethods/design: The Pollen Low dose Intradermal therapy Evaluation (PollenLITE) is a single centre double-blind\r\nrandomised parallel group controlled trial of the efficacy and safety of intradermal grass pollen injections plus standard\r\ntreatment, versus histamine injections plus standard treatment, in adults with moderate-severe grass pollen-induced\r\nallergic rhinitis (ââ?¬Ë?summer hay feverââ?¬â?¢). A minimum of ninety adults with a history of moderate-severe persistent allergic\r\nrhinitis during the UK grass pollen season will be randomised into two equal groups to receive 7 or 8 intradermal\r\ninjections of grass pollen extract (containing approximately 7 ng of major allergen Phl p 5) or histamine, before the\r\ngrass pollen season. In the summer, participants will score their symptoms, medication requirements, visual analogue\r\nscores, and complete EuroQOL (EQ-5D-5 L) and mini Rhinoconjunctivitis Quality of Life Questionnaires. Global\r\nassessments will also be recorded at the end of the pollen season. Blood samples will be collected from all participants\r\nfor mechanistic immune assays. Skin punch biopsies will also be collected in 40 participants selected at random from\r\nintradermal injection sites after the grass pollen season for mechanistic assays. Finally, to investigate if the desensitising\r\neffect of intradermal immunotherapy on cutaneous responses is long-lasting, all participants will be randomised to\r\nreceive a follow up intradermal injection after 3, 6 or 12 months with measurement of early and late response sizes.\r\nDiscussion: Randomisation began in February 2013 and the final participant will complete the trial protocol in\r\nAugust 2014.
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