Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

Summary

The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.

Timeline

Start

1996-03-12

Primary completion

1996-07-01

Completion

1996-07-01

Outcome

Met primary endpoint

registry analysis (superiority test); MFNS 25 mcg QD vs Placebo; p = 0.01; ANOVA NCT03879772 ↗

registry analysis (superiority test); MFNS 100 mcg QD vs Placebo; p = 0.01; ANOVA NCT03879772 ↗

registry analysis (superiority test); MFNS 200 mcg QD vs Placebo; p = 0.02; ANOVA NCT03879772 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mometasone furoate	Other / unclassified	25 ug	Intranasal
Subject	Mometasone furoate	Other / unclassified	100 ug	Intranasal
Subject	Mometasone furoate	Other / unclassified	200 ug	Intranasal
Comparator	beclomethasone dipropionate	Other / unclassified	84 ug	Intranasal
Background	Chlorpheniramine	Unknown	0.4 mg/ml	Oral

Indications