Clinical efficacy of N-acetyl-aspartyl-glutamic acid nasal spray in children suffering from pollinosis: a double-blind multicentre study.
A double-blind, four-centre study was carried out in 66 children to compare the clinical efficacy and safety of N-acetyl-aspartyl-glutamic acid (NAAGA) and disodium cromoglycate (DSCG) nasal sprays. At similar dosage conditions (one puff per nostril, four times daily, for 3 weeks), no significant differences between the treatments were discernible in the primary efficacy parameters (scores, patients' and physicians' opinion). Both products induced statistically significant improvements in the nasal, ocular and total scores, but not in the respiratory (breathing) score. The hay-fever symptoms improved clinically in > 50% of the children after only two weeks with both treatments. The exact figures depended on the parameters considered. Thirteen out of 25 patients (52%) in the NAAGA group found the efficacy "good" or "excellent" at the end of the treatment period; the corresponding opinion in the DSCG group was expressed by 10 out of 24 patients (41.7%). Of the 28 patients that used the rescue medication, 12 (42.8%) were from the NAAGA group and 16 (57.1%) from the DSCG group. One patient on NAAGA treatment reported side effects, i.e. pruritus in the nose and sneezing.
Bertrand
B
B
Cliniques Universitaires, Saint Luc, Yvoir, Belgium.
Dab
R
R
Daele
J
J
van Cauwenberge
P
P
van den Broeck
R
R
D000281:Administration, Intranasal; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004205:Cromolyn Sodium / Q000008:administration & dosage / Q000627:therapeutic use; D004151:Dipeptides / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D009330:Nebulizers and Vaporizers; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*
D004151:Dipeptides; D006634:Histamine H1 Antagonists; C027172:isospaglumic acid; D004205:Cromolyn Sodium