M Calderón1, M Essendrop. 1. Upper Respiratory Medicine, Royal Brompton Hospital, Imperial College, London, United Kingdom m.calderon@imperial.ac.uk
Abstract
BACKGROUND: Sublingual immunotherapy with grass allergen tablets may be the future treatment for grass pollen allergy because it reduces symptoms and medication use, improves quality of life and is easy to use. Rhinoconjunctivitis and asthma co-exist and we aimed to find a safe dose range of a self-administered grass allergen tablet (ALK Abello A/S) in patients suffering from rhinoconjunctivitis and asthma. METHODS: Four doses were investigated in a randomised, double-blind, placebo-controlled, dose escalation trial. Outside the pollen season 4 groups of 12 patients commenced treatment in a staggered manner, at intervals of 1 week. For 28 days doses of 75000 (approximately 15microg Phleum pratense protein 5), 150,000, 300,000, 500,000 standardised quality tablet (SQ-T) units or placebo were given once daily as sublingual tablets. RESULTS: Fourty three patients were randomised to receive either active treatment or placebo (3:1). Each dose group consisted of 12 patients except the 500000 SQ-T group (5 active, 2 placebo). No asthma exacerbations were seen and no serious or severe adverse events were reported. The majority of adverse events were local reactions. The number of adverse events was dose related. No patients withdrew from the study. CONCLUSIONS: Treatment with grass allergen tablets in doses up to 500000 SQ-T in patients with asthma and rhinoconjunctivitis was safe and well tolerated.
RCT Entities:
BACKGROUND: Sublingual immunotherapy with grass allergen tablets may be the future treatment for grass pollen allergy because it reduces symptoms and medication use, improves quality of life and is easy to use. Rhinoconjunctivitis and asthma co-exist and we aimed to find a safe dose range of a self-administered grass allergen tablet (ALK Abello A/S) in patients suffering from rhinoconjunctivitis and asthma. METHODS: Four doses were investigated in a randomised, double-blind, placebo-controlled, dose escalation trial. Outside the pollen season 4 groups of 12 patients commenced treatment in a staggered manner, at intervals of 1 week. For 28 days doses of 75000 (approximately 15microg Phleum pratense protein 5), 150,000, 300,000, 500,000 standardised quality tablet (SQ-T) units or placebo were given once daily as sublingual tablets. RESULTS: Fourty three patients were randomised to receive either active treatment or placebo (3:1). Each dose group consisted of 12 patients except the 500000 SQ-T group (5 active, 2 placebo). No asthma exacerbations were seen and no serious or severe adverse events were reported. The majority of adverse events were local reactions. The number of adverse events was dose related. No patients withdrew from the study. CONCLUSIONS: Treatment with grass allergen tablets in doses up to 500000 SQ-T in patients with asthma and rhinoconjunctivitis was safe and well tolerated.
Authors: Angel Moral; Victoria Moreno; Francisco Girón; David El-Qutob; José D Moure; Manuel Alcántara; Antonia Padial; Alberto G Oehling; Carmen Millán; Fernando de la Torre Journal: J Asthma Allergy Date: 2016-06-29
Authors: Alessandra Scaparrotta; Marina Attanasi; Marianna I Petrosino; Paola Di Filippo; Sabrina Di Pillo; Francesco Chiarelli Journal: Drug Des Devel Ther Date: 2015-11-03 Impact factor: 4.162