MedTrace Logo

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

NCT01471340 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11744

Last updated 2024-05-23

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-09
Primary Completion
2016-11-30
Completion
2016-11-30
FDA Drug
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471340 on ClinicalTrials.gov