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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 Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on November 27, 2014
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 Sharp & Dohme Corp.

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 (Argentina) Inc., Buenos Aires, Argentina; Recruiting
Alfredo Wilkinson, Phone: 54 11 4796 8200

Merck Sharp & Dohme, North Ryde, Australia; Recruiting
Gary Jankelowitz, Phone: 61 2 8988 8246

MSD Brasil, Sao Paulo, Brazil; Recruiting
Ricardo Germano, Phone: 55 11 51897942

Merck Sharp & Dohme Bulgaria EOOD, Sofia, Bulgaria; Recruiting
Eran Gefen, Phone: 38 (044) 393 74 80

Merck Sharp & Dohme (I.A.) Corp., Santiago, Chile; Recruiting
Maria Elena Azara Hernandez, Phone: 56 2 6558958

MDS Colombia SAS, Bogota, Colombia; Recruiting
Francesca Carvajal, Phone: 57 1219109011090

Merck Sharp & Dohme d.o.o, Zagreb, Croatia; Recruiting
Andina Hrabar, Phone: 385 14878400

Merck Sharp and Dohme s.r.o., Praha, Czech Republic; Recruiting
Simona Martinkova, Phone: 420 233010213

Merck Sharp & Dohme OU, Tallinn, Estonia; Recruiting
Andrius Bacevicius, Phone: 370 52780243

MSD France, Paris, France; Recruiting
Dominique Blazy, Phone: 33 147548990

Merck Sharp & Dohme GmbH, Haar, Germany; Recruiting
German Medical Information Center, Phone: 49 800 673 673 673

MSD Pharma Hungary Kft., Budapest, Hungary; Recruiting
Simona Martinkova, Phone: 36 1 457 8522

MSD Ireland (Human Health) Ltd., Dublin, Ireland; Recruiting
Colm Galligan, Phone: 353 12998700

Merck Sharp & Dohme Co. Ltd., Hod Hasharon, Israel; Recruiting
Ofer Sharon, Phone: 972 9 9539310

MSD Italia S.r.l., Rome, Italy; Recruiting
Patrizia Nardini, Phone: 39 06 361911

MSD Korea LTD, Seoul, Korea, Republic of; Recruiting
Cem Ozesen, Phone: 90 212 3361260

Merck Sharp & Dohme Latvija SIA, Riga, Latvia; Recruiting
Andrius Bacevicius, Phone: 370 52780243

MSD, Petaling Jaya, Malaysia; Recruiting
Boon Hock Yeoh, Phone: 60 377181723

MSD, Mexico City, Mexico; Recruiting
Juan Marques, Phone: 52 55254819608

Merck Sharp & Dohme, Peru S.R.L., Lima, Peru; Recruiting
Oscar Espinoza, Phone: (51-1) 411-5100

MSD Polska Sp. Z o.o., Warsaw, Poland; Recruiting
Adam Czernik, Phone: 48 22 4784324

Call for Information (Investigational Site 1239), Cidra 00739, Puerto Rico; Recruiting

Call for Information (Investigational Site 1240), Ponce 00717, Puerto Rico; Recruiting

Call for Information (Investigational Site 1238), San Juan 00909, Puerto Rico; Recruiting

Merck Sharp & Dohme Romania SRL, Bucharest, Romania; Recruiting
Simona Olaru, Phone: 38 (044) 393 74 80

Merck Sharp & Dohme IDEA, Inc., Moscow, Russian Federation; Recruiting
Maria Koroleva, Phone: 7 0959410000

Merck Sharp & Dohme, Belgrade, Serbia; Recruiting
Eran Gefen, Phone: 38 (044) 393 74 80

Merck Sharp Dohme S.R.O., Bratislava, Slovakia; Recruiting
Eva Kaszasova, Phone: 420 233010213

MSD (Pty) LTD South Africa, Midrand, South Africa; Recruiting
Khanyi Mzolo, Phone: 27 11 655 3140

Merck Sharp and Dohme de Espana S.A., Madrid, Spain; Recruiting
Joaquin Mateos Chacon, Phone: 34913210428

Merck Sharp & Dohme (I.A.) Corp., Taipei, Taiwan; Recruiting
Diana Zhang, Phone: 886-2-66316030

MSD Ukraine LLC, Kiev, Ukraine; Recruiting
Eran Gefen, Phone: 38 (044) 393 74 80

Merck Sharp & Dohme Ltd., Hoddesdon, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992452396

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Merck Canada, Kirkland, Quebec H9H 3L1, Canada; Recruiting
Medical Information Centre / Centre de l'information medicale de Merck Canada, Phone: 514-428-8600 / 1-800-567-2594

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Additional Information

Starting date: January 2012
Last updated: November 19, 2014

Page last updated: November 27, 2014

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