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

NCT00521599 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 672

Last updated 2024-05-23

Study results available
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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

DRUG

Mometasone furoate dry powder inhaler

DRUG

Placebo

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-03-31
Completion
2009-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00521599 on ClinicalTrials.gov