A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3)
Information source: Merck
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Mometasone Furoate/Formoterol MDI 100/5 mcg (Drug); Mometasone Furoate/Formoterol MDI 200/5 mcg (Drug); Mometasone Furoate MDI 100 mcg (Drug); Mometasone Furoate MDI 200 mcg (Drug); Albuterol 90 mcg /salbutamol 100 mcg HFA MDI (Drug); Prednisone/prednisolone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Merck Overall contact:
Toll Free Number, Phone: 1-888-577-8839
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.
Clinical Details
Official title: 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)
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Time-to-first serious asthma outcomes (a composite endpoint defined as asthma-related: hospitalizations, intubations, and deaths)
Secondary outcome: Time-to-first asthma exacerbation
Detailed description:
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under
Amendment 1.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme/Australia, South Granville NSW 2142, Australia; Recruiting
Gary Jankelowitz, Phone: 61-2-9795-9500
Merck Sharp & Dohme d.o.o, Zagreb 10 010, Croatia; Recruiting
Andina Hrabar, Phone: 38514878400
Merck Sharp and Dohme s.r.o., Praha 162 00, Czech Republic; Recruiting
Simona Martinkova, Phone: 420233010213
MSD Ireland (Human Health) Ltd., Dublin 18, Ireland; Recruiting
Colm Galligan, Phone: 35312998700
Merck Sharp & Dohme Latvija SIA, Riga 1013, Latvia; Recruiting
Andrius Bacevicius, Phone: 37052780243
MSD Polska Sp. Z o.o., Warszawa 00-867, Poland; Recruiting
Adam Czernik, Phone: 48 22 4784324
Merck Sharp & Dohme (I.A.) Corp., Carolina 630, Puerto Rico; Recruiting
Felipe Arbelaez, Phone: (787) 474-8200
Merck Sharp & Dohme IDEA, Inc., Bratislava, Slovakia; Recruiting
Eva Kaszasova, Phone: 420233010213
Merck Sharp and Dohme de Espana S.A., Madrid 28027, Spain; Recruiting
Cesar Sanz Rodriguez, Phone: 34913210600
Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 441992452396
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Joyce Cox, Phone: 1-800-361-2353
Additional Information
Starting date: January 2012
Last updated: January 30, 2013
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