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Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)

NCT01615874 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-16

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.

Conditions

Interventions

DRUG

MF/F Metered Dose Inhaler (MDI) 25/5 mcg

MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID)

DRUG

MF/F MDI 50/5 mcg

MF/F MDI 50/5 mcg, 2 inhalations BID

DRUG

MF/F MDI 100/5 mcg

MF/F MDI 100/5 mcg, 2 inhalations BID

DRUG

BDP hydrofluoroalkane (HFA) 80 mcg

BDP HFA 80 mcg, 2 inhalations BID

DRUG

Montelukast tablets 5 mg (4 mg for children 5 years of age)

Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age OR Montelukast chewable tablets 4 mg QD for children 5 years of age

DRUG

Rescue medication: short-acting beta-2 agonist (SABA) MDI

albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed

DRUG

Rescue medication: Prednisone/Prednisolone

Prednisone/Prednisolone for rescue medication, taken as directed

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-09-30

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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 NCT01615874 on ClinicalTrials.gov