Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis

Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.

Abstract

Background: GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid).

Objective: To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR).

Methods: In this double-blind study, eligible patients (≥12 years of age) with SAR were randomized 1:1:1:1 to twice-daily GSP301 (665 μg of olopatadine and 25 μg of mometasone), olopatadine (665 μg), mometasone (25 μg), or placebo for 14 days. The primary end point-mean change from baseline in average morning and evening 12-hour reflective Total Nasal Symptom Score (rTNSS)-was analyzed via a mixed-effect model repeated measures (P < .05 was considered to be statistically significant). Additional assessments included average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs).

Results: A total of 1176 patients were randomized. GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (least squares mean difference, -1.09; 95% CI, -1.49 to -0.69; P < .001) and vs olopatadine (P = .03) and mometasone (P = .02). Similar significant improvements in iTNSS were also observed with GSP301 (P < .05 for all). Furthermore, GSP301 significantly improved overall ocular symptoms, individual nasal and ocular symptoms, and quality of life vs placebo (P ≤ .001 for all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent timepoints. Treatment-emergent AEs occurred in 15.6%, 12.6%, 9.6%, and 9.5% of patients in the GSP301, olopatadine, mometasone, and placebo groups, respectively.

Conclusion: GSP301 is efficacious and well tolerated vs placebo for treating SAR-associated nasal and ocular symptoms, with a rapid onset of action of 15 minutes in adult and adolescent patients 12 years and older.

Clinical trial registration: ClinicalTrials.gov: NCT02870205.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Disease Progression
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Histamine Antagonists / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Mometasone Furoate / therapeutic use*
  • Nasal Sprays
  • Olopatadine Hydrochloride / therapeutic use*
  • Quality of Life
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Treatment Outcome
  • Young Adult

Substances

  • Adrenal Cortex Hormones
  • Drug Combinations
  • Histamine Antagonists
  • Nasal Sprays
  • Mometasone Furoate
  • Olopatadine Hydrochloride

Associated data

  • ClinicalTrials.gov/NCT02870205