Selected article for: "adverse effect and clinical study"
Author: Leaker, Brian R.; Singh, Dave; Lindgren, Sam; Almqvist, Gun; Eriksson, Leif; Young, Barbara; O’Connor, Brian
Title: 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
  • Document date: 2019_12_19
    • ID: 15e043uf_18
    Snippet: AZD8848 and matching placebo were administered as nasal spray solutions. The study product contained AZD8848 (0.6 mg·mL − 1 ) in a buffered sterile saline solution that was also used as a matching placebo. The products were provided in glass vials fitted with pump spray devices delivering 50 μL per actuation. AZD8848 was administered in doses of 60 μg (single 30 μg spray into each nostril) and was only administered at the clinic visits, wit.....
    Document: AZD8848 and matching placebo were administered as nasal spray solutions. The study product contained AZD8848 (0.6 mg·mL − 1 ) in a buffered sterile saline solution that was also used as a matching placebo. The products were provided in glass vials fitted with pump spray devices delivering 50 μL per actuation. AZD8848 was administered in doses of 60 μg (single 30 μg spray into each nostril) and was only administered at the clinic visits, with a total of 8 doses administered over a 7-week period. The dosing schedule used in this study was selected on the basis of Phase I/II clinical data [23, 24, 27] . Study drug administration was performed in clinic in a separate room equipped with a fume chamber. The individual nasal spray vials were primed before administration. As the no adverse effect level (NOAEL) for lung exposure was not available at the time of the study, the Investigator or study nurse instructed the patient to exhale orally against a resistance to close the connection between the lungs and the nasal airways. During this manoeuvre, the Investigator or study nurse administered the spray, ensuring delivery to nasal mucosa and avoiding administration of AZD8848 to the lungs.

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