title: Nasal application of a gel formulation of N-acetyl-aspartyl glutamic acid (NAAGA) compared with placebo and disodium cromoglycate in the symptomatic treatment of pollinosis.
abstract: A gel formulation of the antiallergic compound N-acetyl-aspartyl glutamic acid (NAAGA) (Rhinaaxia (R)) has been evaluated in a multicenter, randomized, double-blind, three-arm, parallel-group comparison with placebo gel (P) and disodium cromoglycate (DSCG) in outpatients suffering from seasonal allergic rhinitis (pollinosis). Nose and eye symptoms were assessed daily by the patients on visual analog scales (VAS), and medical examinations were held after 1 week and at the end of the 4-week treatment. The use of rescue medications (H1-antagonist (terfenadine) and soothing eye-drops (Spersallerg) was recorded as a main assessment indicator of efficacy. For the efficacy analysis, only the periods with relevant pollen concentrations (> or = 50 grains/m3) were considered. The study extended over the two pollen seasons 1989 and 1990. Of 230 included patients, 190 were suitable for efficacy analysis (R = 63, P = 64, DSCG = 63). The VAS data did not reveal a difference between the treatment groups for nasal symptoms, whereas the use of terfenadine tablets was significantly lower in the Rhinaaxia group than in either the placebo (P = 0.0001) or DSCG group (P = 0.03). The eye symptoms were significantly less severe in the Rhinaaxia group than in both placebo (P = 0.0001) and DSCG (P < 0.01) groups. In addition, the use of rescue medication was significantly higher in the placebo than in the Rhinaaxia treatment group (P = 0.0001). The incidence of local untoward effects (itching/burning sensation in the nose) was slightly higher in the Rhinaaxia group, while the overall tolerability assessment was similarly good in all three treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Clinical Research Department, Zyma SA, Nyon, Switzerland.
authors.forename: M A
authors.initials: MA
authors.lastname: Althaus
authors.forename: W J
authors.initials: WJ
authors.lastname: Pichler
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D004205:Cromolyn Sodium / Q000627:therapeutic use*; D004151:Dipeptides / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012720:Severity of Illness Index; D013557:Switzerland; D016593:Terfenadine / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004151:Dipeptides; D005782:Gels; D006634:Histamine H1 Antagonists; D009883:Ophthalmic Solutions; C027172:isospaglumic acid; D016593:Terfenadine; D004205:Cromolyn Sodium