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Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)

NCT00383552 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2024-05-17

Study results available
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Summary

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (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 hours) of the change from Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.

Conditions

Interventions

DRUG

Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID

MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks

DRUG

Mometasone Furoate MDI (MF MDI)

MF 100 mcg via metered dose inhaler twice daily for 26 weeks

DRUG

Formoterol Fumarate 10 mcg

F via metered dose inhaler 10 mcg twice a day for 26 weeks

DRUG

Placebo

Placebo metered dose inhaler twice a day for 26 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
2006-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

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Entities

Drugs
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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 NCT00383552 on ClinicalTrials.gov