Montelukast Asthmatic Smoker Study

Condition(s) targeted: Asthma

Intervention: montelukast sodium (Drug); Comparator: fluticasone (Drug); Comparator: Placebo (unspecified) (Drug); Comparator: Placebo (unspecified) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in patients with chronic asthma who actively smoke cigarettes.

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: Evaluate the treatment effect on asthma-control days at 6 months.

Secondary outcome: Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.

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

Merck Sharp & Dohme IDEA Inc., Sofia, Bulgaria; Recruiting
Aneta Sokolova, Phone: 359-2-963-1076

MSD Finland Oy, Espoo 2151, Finland; Recruiting
Eero Helve, Phone: 358-9-804-65280

Vianex, S.A. / MSD, Nea Erythrea 146 71, Greece; Recruiting
Fotini Vlasserou, Phone: 30-210-8009435

MSD Magyarorszag Kft., Budapest 1123, Hungary; Recruiting
Geza Szoverffy, Phone: 36-1 888 5325

Merck Sharp & Dohme Co. Ltd., Petah Tikva 49192, Israel; Recruiting
Raanan Cohen, Phone: 972-3-9274005

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

Merck Sharp & Dohme Idea, Inc, Ljubljana, Slovenia; Recruiting
Karmen Letonja, Phone: 386 1 5204 214

Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34-91-3210-728

Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400

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

UAB Merck Sharp & Dohme, Vilnius, Lietuva, Lithuania; Recruiting
Andrius Bacevicius, Phone: 3705 2 780 243

Merck Sharp & Dohme, Peru S.R.L., Surquillo, Lima LIMA 34, Peru; Recruiting
Jorge Vinces, Phone: 511-411-5933

Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605

(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
Last updated: October 22, 2008