A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.

This study has been completed.

First Received: August 30, 2005 Last Updated: November 24, 2009 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00140946

Purpose

A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

Condition	Intervention	Phase
Asthma	Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks Drug: Comparator: placebo / Duration of Treatment: 16 weeks	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of days of asthma exacerbations

Secondary Outcome Measures:

Percentage of asthma free days
Percentage of nocturnal awakenings
Beta agonist use

Enrollment:	546
Study Start Date:	March 1998
Primary Completion Date:	October 2000 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females between the ages of 18 and 70 with asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140946

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_057, MK0476-075
Study First Received:	August 30, 2005
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00140946 History of Changes
Health Authority:	Spain: Ministry of Health

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Hormone Antagonists
Physiological Effects of Drugs
Budesonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Pharmacologic Actions
Leukotriene Antagonists
Montelukast
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010