Who is sponsoring NCT00746330?

NCT00746330 is sponsored by Novartis.

What drugs are being tested in NCT00746330?

Interventions: Mometasone furoate/formoterol fumarate (MFF), Formoterol fumarate 12 μg pMDI (F12M), Formoterol fumarate 12 μg DPI (F12D), Placebo to F12D, Placebo to F12M/MFF.

What is the status of NCT00746330?

NCT00746330 is currently COMPLETED.

Last reviewed 2011-06-03 · How we verify

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

NCT00746330 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Novartis
Phase	Phase 2
Status	COMPLETED
Enrolment	32
Start date	2008-08
Completion	2009-04

Conditions

Asthma

Interventions

Mometasone furoate/formoterol fumarate (MFF)
Formoterol fumarate 12 μg pMDI (F12M)
Formoterol fumarate 12 μg DPI (F12D)
Placebo to F12D
Placebo to F12M/MFF

Primary outcomes

The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment — From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment).
For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose

Countries

United States, Colombia, Peru