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Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED)

NCT00381485 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2024-05-20

Study results available
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Summary

This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).

Conditions

Interventions

DRUG

Mometasone furoate/formoterol (MF/F) combination

MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks

DRUG

Mometasone furoate/formoterol (MF/F) combination

MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks

DRUG

Mometasone furoate MDI (MF MDI)

MF 400 mcg via metered dose inhaler twice daily for 12 weeks

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-01
Primary Completion
2008-01-01
Completion
2008-01-01

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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 NCT00381485 on ClinicalTrials.gov