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A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution

Trial Profile

A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 17 Oct 2022

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Rhinitis
  • Focus Therapeutic Use
  • Sponsors Johnson & Johnson Consumer Companies

Most Recent Events

  • 01 Mar 2021 As per the results presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology,interim analysis showed the study could be terminated for efficacy with N 206, since the primary efficacy endpoint demonstrated significant results.
  • 01 Mar 2021 Status changed to discontinued as per the results presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
  • 01 Mar 2021 Primary endpoint (Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS)) has been met as per the results presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.

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