NCT01471340

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)

A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11,744 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.

Detailed description

Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mometasone Furoate/Formoterol MDI 100/5 mcg	two inhalations BID
DRUG	Mometasone Furoate/Formoterol MDI 200/5 mcg	two inhalations BID
DRUG	Mometasone Furoate MDI 100 mcg	two inhalations BID
DRUG	Mometasone Furoate MDI 200 mcg	two inhalations BID
DRUG	Albuterol 90 mcg /salbutamol 100 mcg HFA MDI	use as needed for asthma symptoms
DRUG	Prednisone/prednisolone	Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator

Timeline

• Start date: 2012-01-09
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2011-11-16
• Last updated: 2024-05-23
• Results posted: 2018-01-05

Regulatory

• FDA-regulated drug study