A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3)



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:January 2012
End Date:February 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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Trial Summary
Trial Overview
Inclusion Criteria

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)

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.

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

Inclusion Criteria:

- Persistent asthma for at least 1-year

- Must use a daily asthma controller medication for at least 4 weeks prior to
randomization, including an inhaled corticosteroid (ICS) with or without a
long-acting beta agonist (LABA) or other adjunctive asthma therapy OR be using a
leukotriene receptor antagonist (LTRA), xanthine or short acting beta agonist (SABA)
as a monotherapy.

- Must be able to discontinue current asthma medication

- Must have a history of at least one asthma exacerbation in previous 4 to 52 weeks

Exclusion Criteria:

- Unstable asthma

- Taking high dose ICS with or without other adjunctive therapy who have an Asthma
Control Questionnaire 6 (ACQ6) total score ≥ 1.5

- Taking LTRA, xanthine or SABA monotherapy with an ACQ-6 total score < 1.5
(controlled)

- Chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), or other
significant, non-asthmatic, lung disease

- Clinically significant abnormality, illness or disorder of any body or organ system

- Significant underlying cardiovascular condition which may contraindicate use of a
beta-agonist.

- History of smoking greater than 10-pack years

- Had an asthma exacerbation within 4 weeks of the Baseline Visit

- Had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the
randomization visit

- Known or suspected hypersensitivity or intolerance to corticosteroids, beta-2
agonists, or any of the (inactive ingredients) excipients present in the medications
used in this study

- Require the use of chronic systemic steroids, omalizumab, or other monoclonal or
polyclonal antibodies

- Requires the use of beta-blockers

- History of life-threatening asthma, including an asthma episode that required
intubation and/or was associated with hypercapnia requiring noninvasive ventilatory
support

- Lactating, pregnant, or plans to become pregnant during the course of the trial
We found this trial at
1
site
Clinical Trial Facility in Broken Arrow Oklahoma
Broken Arrow, Oklahoma 74012
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mi
from
Broken Arrow, OK
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