PMID- 31734334
OWN - NLM
STAT- MEDLINE
DCOM- 20200427
LR  - 20200427
IS  - 1534-4436 (Electronic)
IS  - 1081-1206 (Linking)
VI  - 124
IP  - 2
DP  - 2020 Feb
TI  - Efficacy and safety of twice-daily and once-daily olopatadine-mometasone 
      combination nasal spray for seasonal allergic rhinitis.
PG  - 171-178.e2
LID - S1081-1206(19)31387-0 [pii]
LID - 10.1016/j.anai.2019.11.007 [doi]
AB  - BACKGROUND: GSP301 is an investigational fixed-dose combination nasal spray of 
      olopatadine hydrochloride (antihistamine) and mometasone furoate 
      (corticosteroid). OBJECTIVE: To evaluate efficacy and safety of GSP301 in 
      patients with seasonal AR (SAR). METHODS: In this phase 2, double-blind, 
      parallel-group study, patients (>/=12 years of age) with SAR were equally 
      randomized to twice-daily GSP301 (olopatadine 665 mug and mometasone 25 mug), 
      once-daily GSP301 (olopatadine 665 mug and mometasone 50 mug), twice-daily or 
      once-daily olopatadine monotherapy (665 mug), mometasone monotherapy (twice-daily 
      25 mug or once-daily 50 mug), or placebo for 14 days. The primary endpoint-mean 
      change from baseline in morning and evening reflective Total Nasal Symptom Score 
      (rTNSS)-was analyzed using analysis of covariance (ANCOVA; P < .05 = 
      statistically significant). Average morning and evening 12-hour instantaneous 
      TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of 
      life, and adverse events (AEs) were also assessed. RESULTS: A total of 1111 
      patients were randomized. Twice-daily GSP301 provided statistically significant 
      and clinically meaningful rTNSS improvements vs placebo (P < .001), twice-daily 
      olopatadine (P = .049), and mometasone (P = .004). Similar significant 
      improvements in iTNSS were observed with twice-daily GSP301 vs placebo (P < .001) 
      and twice-daily mometasone (P = .007); improvements were not significant vs 
      olopatadine (P = .058). Once-daily GSP301 provided significant rTNSS and iTNSS 
      improvements vs placebo and once-daily olopatadine (P < .01, all) but 
      improvements were not significant vs mometasone. Treatment-emergent AEs rates 
      were 10.8%, 9.5%, and 8.2%, with twice-daily GSP301, once-daily GSP301, and 
      placebo, respectively. CONCLUSION: Twice-daily GSP301 treatment was efficacious 
      and well tolerated, providing statistically significant and clinically meaningful 
      improvements in rTNSS (primary endpoint) vs placebo and both monotherapies. TRIAL 
      REGISTRATION: Clinicaltrials.gov Identifier NCT02318303.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Andrews, Charles P
AU  - Andrews CP
AD  - Diagnostics Research Group, San Antonio, Texas. Electronic address: 
      candrews@dxrg.com.
FAU - Mohar, Dale
AU  - Mohar D
AD  - Kerrville Research Associates, Kerrville, Texas.
FAU - Salhi, Yacine
AU  - Salhi Y
AD  - Glenmark Pharmaceuticals Inc, Paramus, New Jersey.
FAU - Tantry, Sudeesh K
AU  - Tantry SK
AD  - Glenmark Pharmaceuticals Inc, Paramus, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT02318303
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191115
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 0 (Drug Combinations)
RN  - 0 (Nasal Sprays)
RN  - 04201GDN4R (Mometasone Furoate)
RN  - 2XG66W44KF (Olopatadine Hydrochloride)
SB  - IM
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mometasone Furoate/*administration & dosage/adverse effects
MH  - Nasal Sprays
MH  - Olopatadine Hydrochloride/*administration & dosage/adverse effects
MH  - Rhinitis, Allergic, Seasonal/diagnosis/*drug therapy
MH  - Treatment Outcome
EDAT- 2019/11/18 06:00
MHDA- 2020/04/28 06:00
CRDT- 2019/11/18 06:00
PHST- 2019/06/14 00:00 [received]
PHST- 2019/11/01 00:00 [revised]
PHST- 2019/11/06 00:00 [accepted]
PHST- 2019/11/18 06:00 [pubmed]
PHST- 2020/04/28 06:00 [medline]
PHST- 2019/11/18 06:00 [entrez]
AID - S1081-1206(19)31387-0 [pii]
AID - 10.1016/j.anai.2019.11.007 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 
      10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.