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Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)

NCT00635882 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-05-14

Study results available
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Summary

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma.

Conditions

Interventions

DRUG

mometasone furoate/formoterol 100/10 mcg

mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days

DRUG

mometasone furoate/formoterol 200/10 mcg

mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days

DRUG

mometasone furoate/formoterol 400/10 mcg

mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days

DRUG

MF DPI 200 mcg

MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days

DRUG

MF MDI 200 mcg

MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days

DRUG

Placebo

MF/F MDI placebo twice daily (BID) (2 inhalations)

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-06-30
Completion
2009-06-30

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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 NCT00635882 on ClinicalTrials.gov