Montelukast Asthmatic Smoker Study
Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast sodium (Drug); Comparator: Placebo (Drug); Comparator: fluticasone (Drug); Comparator: Placebo. (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in
patients with chronic asthma who actively smoke cigarettes.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of asthma-control days over the 6-month treatment period
Secondary outcome: AM Peak Expiratory Flow Rate (PEFR) and daytime symptom score over the 6-month treatment period
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with chronic asthma who actively smoke at least 0. 5 to no more than 2 packs
of cigarettes a day
Exclusion Criteria:
- Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or
emphysema
Locations and Contacts
Merck Sharp & Dohme IDEA Inc., Sofia, Bulgaria; Recruiting
Aneta Sokolova, Phone: 359-2-963-1076
Vianex, S.A. / MSD, Nea Erythrea 146 71, Greece; Recruiting
Fotini Vlasserou, Phone: 30-210-8009435
MSD Korea Ltd., Seoul 121-705, Korea, Republic of; Recruiting
Steve Kim, Phone: 82-2-6363-0241
Merck Sharp & Dohme (I.A.) Corp, Selangor 46300, Malaysia; Recruiting
Nazrin Azli, Phone: 603-77181748
Merck Sharp & Dohme (I.A.) Corporation, Makati City 1229, Philippines; Recruiting
Cesar "Butch" Recto II, Phone: 632-885-0700
Merck Sharp & Dohme Lda, Paco D`arcos 2770-192, Portugal; Recruiting
Lai Hung Jen, Phone: 351-21-4465821
MSD Bucharest, Bucharest Sector 1, Romania; Recruiting
Marius R. Ursa, Phone: 4021 316 8353
Merck Sharp & Dohme IDEA, Inc., Moscow 121059, Russian Federation; Recruiting
Tatiana Serebriakova, Phone: 7-495-941-8264
Merck Sharp & Dohme Idea, Inc, Ljubljana, Slovenia; Recruiting
Karmen Letonja, Phone: 386 1 5204 214
Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F. 1090, Mexico; Recruiting
Juan Diaz, Phone: 52-55-5481-9825
Merck Sharp & Dohme IDEA, Inc., Tallinn, Eesti 11415, Estonia; Recruiting
Andrius Bacevicius, Phone: 370-5-2780-243
MSD (Pty) LTD South Africa, Midrand, Gauteng 1685, South Africa; Recruiting
Beverley Cowper, Phone: 27 11 655-3036
Merck Sharp & Dohme Ilaclari Ltd. Sti, Istinye, Istanbul 34460, Turkey; Recruiting
Meltem Telaferli, Phone: 90 212 365 5354
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: May 2006
Ending date: May 2010
Last updated: October 14, 2009
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