PMID- 19243710
OWN - NLM
STAT- MEDLINE
DCOM- 20090407
LR  - 20151119
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 31
IP  - 1
DP  - 2009 Jan
TI  - Effects of olopatadine hydrochloride nasal spray 0.6% in the treatment of 
      seasonal allergic rhinitis: a phase III, multicenter, randomized, double-blind, 
      active- and placebo-controlled study in adolescents and adults.
PG  - 99-107
LID - 10.1016/j.clinthera.2009.01.016 [doi]
AB  - BACKGROUND: Seasonal allergic rhinitis (SAR) is an allergen-induced inflammatory 
      reaction that occurs during periods of high pollen count. Current treatments for 
      SAR include allergen avoidance, systemic antihistamines, and steroidal and 
      nonsteroidal intranasal sprays. Olopatadine is a selective antihistamine and an 
      inhibitor of proinflammatory mediators from human mast cells. An intranasal 
      formulation of olopatadine has been developed for the treatment of SAR. 
      OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of 
      olopatadine hydrochloride nasal spray 0.6% (OLO) relative to azelastine 
      hydrochloride nasal spray 0.1% (AZE) and an inactive vehicle in the treatment of 
      SAR. METHODS: This Phase III, multicenter, randomized, double-blind, active- and 
      placebo-controlled, parallel-group study was conducted at 21 centers across the 
      United States. Eligible patients were aged > or =12 years and had a history of 
      SAR and verified allergy to a prevalent local allergen. After a run-in period 
      during which inactive vehicle was administered, patients were randomly assigned 
      to OLO, AZE (active control), or inactive vehicle (identical to OLO; placebo 
      control), 2 sprays in each nostril BID for 16 days. The timing of enrollment was 
      correlated with the start of the allergy season at each site. Symptoms were 
      recorded twice daily in an electronic diary. Efficacy assessments included 
      changes in mean daily reflective total nasal symptom scores (TNSS). Tolerability 
      was evaluated based on adverse events (AEs) and nasal, physical, and 
      cardiovascular parameters. RESULTS: A total of 544 patients were randomized. The 
      mean age was 36 years (range, 12-77 years); men and boys represented 32.2% of the 
      population; and the patients were predominantly white (75.4%). The mean 
      reductions from baseline in reflective TNSS were 26.8%, 29.9%, and 18.4% with 
      OLO, AZE, and inactive vehicle, respectively (P = 0.003 OLO vs inactive vehicle; 
      95% CI, -2.5% to 8.7% OLO vs AZE [non-inferiority]). The most commonly reported 
      treatment-related AE in the OLO and AZE groups was bitter taste (12.2% [22/180] 
      and 19.7% [37/188], respectively). The prevalence and intensity of bitter taste 
      were significantly lower with OLO than with AZE (P = 0.05 and P = 0.005, 
      respectively). In the group that received inactive vehicle, the prevalence of 
      bitter taste was 1.7% (3/176). The prevalences of other treatment-related AEs, 
      including epistaxis and nasal discomfort, were < or =3.7% in each group and did 
      not differ significantly between groups. CONCLUSIONS: In this small study in 
      patients aged > or =12 years with SAR, the percentage reduction from baseline in 
      TNSS was significantly greater with OLO (2 sprays in each nostril BID) compared 
      with vehicle and not significantly different from that with AZE. OLO and AZE were 
      similarly well tolerated, with the exception of prevalence and intensity of 
      bitter taste, which were significantly lower with OLO.
FAU - Shah, Shailen R
AU  - Shah SR
AD  - Allergy and Asthma Consultants of NJ-PA, Collegeville, Pennsylvania, USA. 
      shah@comcast.net
FAU - Nayak, Anjuli
AU  - Nayak A
FAU - Ratner, Paul
AU  - Ratner P
FAU - Roland, Peter
AU  - Roland P
FAU - Michael Wall, G
AU  - Michael Wall G
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Dibenzoxepins)
RN  - 0 (Phthalazines)
RN  - 2XG66W44KF (Olopatadine Hydrochloride)
RN  - ZQI909440X (azelastine)
SB  - IM
MH  - Administration, Intranasal
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Allergic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Child
MH  - Dibenzoxepins/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Epistaxis/chemically induced
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Olopatadine Hydrochloride
MH  - Phthalazines/administration & dosage/adverse effects/*therapeutic use
MH  - Rhinitis, Allergic, Seasonal/drug therapy
MH  - Taste
MH  - United States/epidemiology
MH  - Young Adult
EDAT- 2009/02/27 09:00
MHDA- 2009/04/08 09:00
CRDT- 2009/02/27 09:00
PHST- 2008/12/10 00:00 [accepted]
PHST- 2009/02/27 09:00 [entrez]
PHST- 2009/02/27 09:00 [pubmed]
PHST- 2009/04/08 09:00 [medline]
AID - S0149-2918(09)00030-7 [pii]
AID - 10.1016/j.clinthera.2009.01.016 [doi]
PST - ppublish
SO  - Clin Ther. 2009 Jan;31(1):99-107. doi: 10.1016/j.clinthera.2009.01.016.