Effects of the Toll-like receptor 7 (TLR7) agonist, AZD8848, on allergen-induced responses in patients with mild asthma: a double-blind, randomised, parallel-group study

Leaker, Brian R.; Singh, Dave; Lindgren, Sam; Almqvist, Gun; Eriksson, Leif; Young, Barbara; O’Connor, Brian

AZD8848 was generally well tolerated, with influenza-like symptoms reported more frequently during the AZD8848 treatment period (58%), compared with placebo (24%) ( Table 2) . No deaths occurred during the study and the only serious AE reported (bacterial tonsillitis) occurred in the placebo group. AEs leading to discontinuation of study treatment (DAEs) occurred in 15% of AZD8848 and 8% of placebo recipients. One patient in each treatment group discontinued due to asthma related events and 1 patient in each treatment group discontinued due to raised transaminases. In the AZD8848 group, other DAEs included pyrexia, back pain and loss of consciousness for 20 s in a female aged 30 years, arthralgia, somnolence and headache in a 24-year-old male. The vast majority of AEs were of mild or moderate intensity, with headache, nasal dryness, arthralgia and pyrexia the most commonly reported AEs related to AZD8848 treatment (Table 3) . Nasal symptoms (including epistaxis, rhinorrhoea, nasal congestion/obstruction, sneezing, nasal dryness, and nasal ulcer) were equally distributed between treatments. No clinically relevant changes in vital signs/electrocardiographic parameters were observed.