A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray as Compared to the FDC of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Olopatadine Nasal Spray, and Placebo in Patients With Seasonal Allergic Rhinitis.

Trial Profile

A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray as Compared to the FDC of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Olopatadine Nasal Spray, and Placebo in Patients With Seasonal Allergic Rhinitis.

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Mar 2018

At a glance

  • Drugs Mometasone/olopatadine (Primary) ; Azelastine/fluticasone-propionate; Olopatadine
  • Indications Seasonal allergic rhinitis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Glenmark Pharmaceuticals Ltd
  • Most Recent Events

    • 06 Mar 2018 According to a Glenmark Pharmaceuticals media release, data were presented at the AAAAI/WAO Joint Congress.
    • 06 Mar 2018 Results presented in a Glenmark Pharmaceuticals Media Release.
    • 05 Mar 2018 Primary endpoint (Change in mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment) has been met as per the results presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
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