drugset / Trial / 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)

NCT01615874

Phase 2 Withdrawn Organon and Co
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2013-01
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 5 ug Inhaled
Subject Mometasone furoate Other / unclassified 25 ug Inhaled
Subject Mometasone furoate Other / unclassified 50 ug Inhaled
Subject Mometasone furoate Other / unclassified 100 ug Inhaled
Comparator Montelukast Other / unclassified 4 mg Oral
Comparator Montelukast Other / unclassified 5 mg Oral
Comparator beclomethasone dipropionate Other / unclassified 80 ug Inhaled
Background Prednisolone Other / unclassified
Background Prednisone Other / unclassified
Background Salbutamol Unknown 90 ug Inhaled
Background Salbutamol Unknown 100 ug Inhaled

Indications