Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar.
BACKGROUND
A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar.


OBJECTIVE
To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar.


METHODS
This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms.


RESULTS
Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. Olopatadine spray exhibited a safety profile comparable with that of placebo.


CONCLUSIONS
Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.
Ratner
Paul H
PH
Sylvana Research, San Antonio, Texas 78229, USA. phratner@swbell.net
Hampel
Frank C
FC
Amar
Niran J
NJ
van Bavel
Julius H
JH
Mohar
Dale
D
Marple
Bradley F
BF
Roland
Peter S
PS
Wall
G Michael
GM
Brubaker
Michael J
MJ
Drake
Margaret
M
Turner
Darell
D
Silver
Lewis H
LH
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D003710:Demography; D003990:Dibenzoxepins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D018653:Juniperus / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D000069605:Olopatadine Hydrochloride; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D000069605:Olopatadine Hydrochloride