Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)

Summary

This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus montelukast (ML) 10 mg daily in the evening.

Timeline

Start

2006-09

Primary completion

2009-10

Completion

2009-10

Outcome

Missed primary endpoint

registry analysis (unspecified test); MF DPI 400 mcg QD PM vs ML 10 mg QD PM; p = 0.261; ANOVA NCT00394355 ↗

paper with no significant differences for MF 400 μg versus ML (-0.3% [95% CI, -1.01 to 0.27]) for LS BMD. PMID 24565713 ↗

Publications

• Results Maspero J, Backer V, Yao R, Staudinger H, Teper A. Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma. J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):649-55.e1. doi: 10.1016/j.jaip.2013.07.011. Epub 2013 Oct 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluticasone propionate	Other / unclassified	250 ug	Inhaled
Subject	Mometasone furoate	Other / unclassified	200 ug	Inhaled
Subject	Mometasone furoate	Other / unclassified	400 ug	Inhaled
Comparator	Montelukast	Other / unclassified	10 mg	Oral

Indications