Clinical Trials Directory

Trials / Completed

CompletedNCT00521599

A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828)

A Study of the Therapeutic Equivalency of MF DPI 100 mcg and 200 mcg Inhalers in Corticosteroid-Dependent Subjects With Moderate Asthma

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

Summary

This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs when providing the same total daily dose (400 mcg/day).

Conditions

Interventions

TypeNameDescription
DRUGMometasone furoate dry powder inhaler
DRUGPlacebo

Timeline

Start date
2007-05-01
Primary completion
2009-03-01
Completion
2009-03-01
First posted
2007-08-28
Last updated
2024-05-23
Results posted
2010-03-23

Source: ClinicalTrials.gov record NCT00521599. Inclusion in this directory is not an endorsement.