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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

Page last updated: February 07, 2013

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