Trial intelligence / Profile preview

Mometasone Furoate Nasal Spray in Children with Seasonal Allergic Rhinitis

NCT03879772Phase 3

Key facts

Status
Completed
Start
Mar 1996
Primary completion
Jul 1996
Modality
Small Molecules
Conditions
seasonal allergic rhinitis (SAR)
01

Overview

Phase 3, randomised, double-blind trial of mometasone furoate nasal spray in seasonal allergic rhinitis (SAR) (5 arms), sponsored by Organon & Co. Primary endpoint: Total Nasal Symptom Score at Day 8. Started Mar 1996; status: completed.

02

Design

5 arms
Study design
RandomizedDouble-blind
  • MFNS 25 mcg QD

    Mometasone furoate 25 mcg QD

  • MFNS 100 mcg QD

    Mometasone furoate 100 mcg QD

  • MFNS 200 mcg QD

    Mometasone furoate 200 mcg QD

  • BDP 84 mcg BID

    Beclomethasone dipropionate 84 mcg BID

  • Placebo

    Placebo nasal spray

03

Who it enrols

Children 6-11 with seasonal allergic rhinitis history >1 year and positive skin test. Excludes asthma requiring steroids, sinusitis, structural abnormalities, and recent infections.

04

Endpoints

Primary

  • Total Nasal Symptom Score

Secondary

  • Total Nasal Symptom Score

05

Results

Primary endpoints met

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