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


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


METHODS
This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 565 patients aged 12 to 80 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 and completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).


RESULTS
Olopatadine spray (0.4% and 0.6%) was significantly superior to placebo for percentage change from baseline in overall reflective (P = .004 and P < .001, respectively) and instantaneous (P = .02 and P = .003, respectively) TNSSs. Also, 0.6% olopatadine was significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny and itchy nose, and itchy eyes; the instantaneous assessments of watery eyes; and the overall and all 7 domain scores of the RQLQ (P < .05). 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 (reflective and instantaneous) and in quality-of-life variables in patients with SAR. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.
Meltzer
Eli O
EO
Allergy and Asthma Medical Group and Research Center, San Diego, California 92123, USA. EOMELTZER@aol.com
Hampel
Frank C
FC
Ratner
Paul H
PH
Bernstein
David I
DI
Larsen
Lawrence V
LV
Berger
William E
WE
Finn
Albert F
AF
Marple
Bradley F
BF
Roland
Peter S
PS
Wall
G Michael
GM
Brubaker
Michael J
MJ
Dimas
Carolyn
C
Potts
Susan L
SL
Silver
Lewis H
LH
Barnes
J Rod
JR
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D003990:Dibenzoxepins / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069605:Olopatadine Hydrochloride; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D006634:Histamine H1 Antagonists; D000069605:Olopatadine Hydrochloride