NCT00746330

Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma

A Randomized, Double-blind, Double-dummy, Multi-centre, 4-way Cross-over Study to Compare the Single Dose Bronchodilatory Effect of Formoterol Fumarate in Combination With Mometasone Furoate Delivered Via Pressurized Metered Dose Inhaler (pMDI) to Placebo Delivered Via pMDI in Children Aged 5-11 Years Old With Persistent Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and duration of action), of a single dose of formoterol fumarate in combination with mometasone furoate to placebo in children of 5-11 years with persistent asthma. The study will also assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI) to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted throughout the study to assess systemic exposure following administration of the study medication.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mometasone furoate/formoterol fumarate (MFF)	Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.
DRUG	Formoterol fumarate 12 μg pMDI (F12M)	Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).
DRUG	Formoterol fumarate 12 μg DPI (F12D)	Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).
DRUG	Placebo to F12D	Placebo to formoterol fumarate DPI delivered via DPI
DRUG	Placebo to F12M/MFF	Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-09-04
• Last updated: 2011-06-07
• Results posted: 2011-04-14

Locations

9 sites across 3 countries: United States, Colombia, Peru