NCT00394355

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

Comparative Study of the Effect of Two Doses of Mometasone Furoate Dry Powder Inhaler 200 mcg and 400 mcg QD PM, Fluticasone Propionate 250 mcg BID, and Montelukast 10 mg QD PM, on Bone Mineral Density in Adults With Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 566 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	mometasone furoate dry powder inhaler	400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
DRUG	mometasone furoate dry powder inhaler	200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
DRUG	fluticasone propionate hydrofluoroalkane (HFA)	250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year
DRUG	montelukast	10 mg given once daily in the evening by mouth for 1 year.

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2006-11-01
• Last updated: 2024-05-22
• Results posted: 2011-03-07