NCT00635882

Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)

A 2-Week Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Anti-Inflammatory Effects of Low, Medium, and High Dose Mometasone Furoate/Formoterol Fumarate MDI Formulation and Medium Dose Mometasone Furoate DPI and MDI Formulations in Adults and Adolescents With Persistent Allergic Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma.

Detailed description

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma. An open-label run in period is to be followed by a double-blind treatment period. A total of 90 subjects (15 per treatment) will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation, accounting for a 20% drop-out rate. A sample size of 12 subjects per treatment is required to detect a treatment difference of 28% in percent change of eNO at Day 14, assuming a pooled standard deviation of 20% with a power of 90%. These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by S.A. Kharitonov et. al, 2003. Subjects will be randomized to one of six treatment groups (MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, MF DPI 200 mcg BID, MF MDI 200 mcg BID, or Placebo MDI BID) according to an Schering-Plough Research Institute (SPRI) computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software (SAS).

Conditions

• Asthma
• Airway Inflammation

Interventions

Type	Name	Description
DRUG	mometasone furoate/formoterol 100/10 mcg	mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days
DRUG	mometasone furoate/formoterol 200/10 mcg	mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days
DRUG	mometasone furoate/formoterol 400/10 mcg	mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days
DRUG	MF DPI 200 mcg	MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days
DRUG	MF MDI 200 mcg	MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days
DRUG	Placebo	MF/F MDI placebo twice daily (BID) (2 inhalations)

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-03-14
• Last updated: 2024-05-14
• Results posted: 2011-02-09