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A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)

NCT01502371 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 583

Last updated 2024-06-17

Study results available
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Summary

The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second \[FEV1\]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.

Conditions

Interventions

DRUG

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg

MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks

DRUG

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg

MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks

DRUG

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg

MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks

DRUG

Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg

MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks

DRUG

Placebo Metered Dose Inhaler (MDI)

Placebo MDI, 2 puffs BID for 12 weeks

DRUG

Placebo Dry Powder Inhaler (DPI)

Placebo DPI, 1 puff QD for 12 weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-25
Primary Completion
2015-01-29
Completion
2015-01-29

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Entities

Diseases

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 NCT01502371 on ClinicalTrials.gov