drugset / Trial / NCT00394355

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

NCT00394355

Phase 4 Completed 566 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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