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) [Sechswöchige, gegenüber dem Auswerter verblindete, randomisierte, verumkontrollierte Evaluierung der Wirkungen von drei Dosierungen von Mometasonfuroat/Formoterolfumarat (MF/F) im Dosieraerosol-Inhalator (Metered Dose Inhaler, MDI) sowie von Montelukast und von Beclometasondipropionat (BDP-HFA) auf die HHN-Achse bei asthmatischen Kindern im Alter von 5–11 Jahren]

Trial Profile

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) [Sechswöchige, gegenüber dem Auswerter verblindete, randomisierte, verumkontrollierte Evaluierung der Wirkungen von drei Dosierungen von Mometasonfuroat/Formoterolfumarat (MF/F) im Dosieraerosol-Inhalator (Metered Dose Inhaler, MDI) sowie von Montelukast und von Beclometasondipropionat (BDP-HFA) auf die HHN-Achse bei asthmatischen Kindern im Alter von 5–11 Jahren]

Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 12 Apr 2013

At a glance

  • Drugs Beclometasone (Primary) ; Mometasone/formoterol (Primary) ; Montelukast (Primary)
  • Indications Asthma
  • Focus Pharmacokinetics
  • Sponsors Merck & Co; Merck Sharp & Dohme
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 14 Nov 2012 Status changed from recruiting to withdrawn prior to recruitment as reported by ClinicalTrials.gov.
    • 03 Nov 2012 Planned number of patients changed from 145 to 162 as reported by European Clinical Trials Database.
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