NCT00424008

Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)

A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 722 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mometasone furoate/formoterol (MF/F) MDI	MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
DRUG	Fluticasone propionate/salmeterol (F/SC) DPI	Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-01-18
• Last updated: 2024-05-20
• Results posted: 2010-11-01