Montelukast Asthmatic Smoker Study - Tabular View

Tracking Information

First Received Date ^ICMJE

January 31, 2006

Last Updated Date

November 20, 2009

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of asthma-control days over the 6-month treatment period [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00284856 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Average change from baseline in mean daytime symptom score over a 6-month treatment period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in average AM PEFR (peak expiratory flow rate) over a 6-month treatment period [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Montelukast Asthmatic Smoker Study

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: montelukast sodium
Drug: Comparator: Placebo
Drug: Comparator: fluticasone
Drug: Comparator: Placebo.

Study Arms / Comparison Groups

Experimental: Arm 1: Drug
Active Comparator: Arm 2: Active Comparator
Placebo Comparator: Arm 3: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

April 2011

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00284856

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_108, MK0476-332

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP