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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions

Asthma

Interventions

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

Trial Locations (9)

32503

Novartis Investigative Site, Pensacola

33012

Novartis Investigative Site, Hialeah

36608

Novartis Investigative Site, Mobile

73112

Novartis Investigative Site, Oklahoma City

92647

Novartis Investigative Site, Huntington Beach

92868

Novartis Investigative Site, Orange

Unknown

Novartis Investigative Site, Barranquilla

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Lima