NCT01615874

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)

A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthmatic Children 5 to 11 Years of Age (Protocol No. P05574/PN158)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-06-11
• Last updated: 2022-02-16