A cross-over comparison of acrivastine, pseudoephedrine and their combination in seasonal allergic rhinitis.
In a four period, double-blind cross-over study, forty patients with moderate to severe symptoms of seasonal allergic rhinitis received in randomised order 8 mg acrivastine, 60 mg pseudoephedrine, 8 mg acrivastine plus 60 mg pseudoephedrine and placebo. Each treatment was given three times daily for six days with a one day washout period between treatments. Acrivastine alone significantly reduced all the symptom severity scores when compared to placebo or pseudoephedrine alone (p less than 0.01). These severity scores were assigned daily by patients for itchy nose/throat, sneezing, running nose, blocked nose, watery eyes, itchy eyes and overall symptoms. The combination of acrivastine and pseudoephedrine was significantly better than either placebo or pseudoephedrine alone in controlling all symptom scores (p less than 0.01) and it was also superior to acrivastine alone (p less than 0.05) in controlling all symptoms except itchy eyes. The results confirm the expected additive rather than synergistic effect of acrivastine and pseudoephedrine in combination. The control of symptoms assessed at the end of each treatment period was considered either excellent or good by 79% of patients and 84% of investigators for acrivastine plus pseudoephedrine and, for acrivastine alone, by 69% of patients and 67% of investigators. Both acrivastine alone and acrivastine and pseudoephedrine in combination were well tolerated. There was no significant difference in the number of adverse experiences reported in either of these two groups compared to the number of adverse experiences reported in the placebo group.
Meran
A
A
HNO-Praxis, Basel, Switzerland.
Morse
J
J
Gibbs
T G
TG
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004809:Ephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D014311:Triprolidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*
D006634:Histamine H1 Antagonists; D011725:Pyridines; D014311:Triprolidine; C043648:acrivastine; D004809:Ephedrine