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A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)

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Trial Profile

A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Feb 2022

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At a glance

  • Drugs Mometasone/olopatadine (Primary) ; Mometasone; Olopatadine
  • Indications Seasonal allergic rhinitis
  • Focus Therapeutic Use
  • Sponsors Glenmark Pharmaceuticals Ltd

    • Most Recent Events

    • 14 Nov 2019 Results assessing efficacy and safety of olopatadine-mometasone for the treatment of seasonal allergic rhinitis, published in the Annals of Allergy, Asthma and Immunology.
    • 25 Feb 2019 Results of a pooled analysis of nasal symptoms and TEAEs from NCT02318303, NCT02631551, NCT02870205 trials, presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 25 Feb 2019 Results of a pooled analysis of Onset of Action and Ocular Symptom from NCT02318303, NCT02631551, NCT02870205 trials, presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
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