Vasomotor rhinitis (VMR) is a common but poorly understood disorder of which there are two major subgroups: VMR(w/t), triggered by weather/temperature and VMR(ir), triggered by airborne irritants. No specific biological pathways or specific treatments for VMR(w/t) or VMR(ir) have been identified. However, intranasal corticosteroids (INSs) are effective in treating many forms of nonallergic rhinitis that include these conditions. A recently introduced INS with established efficacy in allergic rhinitis and enhanced affinity, fluticasone furoate, may possess the potency and safety profile required to treat chronic VMR(w/t). Two replicate studies (FFR30006 and FFR30007) were conducted in six countries to evaluate the efficacy and safety of fluticasone furoate nasal spray in subjects with VMR(w/t). After a 7- to 14-day screening period, subjects (n = 699) with symptomatic VMR(w/t) received fluticasone furoate, 110 mug q.d. or placebo for 4 weeks in these two randomized, double-blind, parallel-group studies. Subjects rated their nasal symptoms (congestion, rhinorrhea, and postnasal drip) twice daily on a 4-point categorical scale and evaluated their overall response to treatment at study end. Fluticasone furoate did not significantly improve daily reflective total nasal symptom scores, the primary end point, versus placebo (p = 0.259) and there was no improvement in any other measure of efficacy. The active treatment was well tolerated. Fluticasone furoate was not effective in treating subjects with a newly defined condition, weather-sensitive VMR. These unexpected results suggest that VMR(w/t) is a distinct subgroup of VMR that is refractory to treatment with INSs. Additional study of other treatments for VMR(w/t) (including INSs) is warranted.
To study the lack of fever during the human newborn period, cord blood leukocytes obtained at birth were stimulated to produce leukocytic pyrogen (LP) in vitro. Phagocytic leukocytes from infants who were born by Caesarean section and whose mothers had not experienced natural onset of labor produced no LP or significantly less LP than leukocytes from adults or from infants born after natural onset of labor. There was a significant difference between total white blood cell count in cord blood of infants whose phagocytic cells produced LP and those whose cells did not. This observation could not be accounted for by anesthetic agents, phagocytosis of staphylococci, or number of leukocytes producing LP; thus, they suggest an intrinsic defect in the ability to produce LP before birth. Of interest is that a nondialyzable substance(s) present in crude preparations of human chorionic gonadotropin markedly suppressed LP production from adult human monocytes, but purified human chorionic gonadotropin had no effect.
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