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A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140946
First Posted: September 1, 2005
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Study Completion Date: October 2000
Primary Completion Date: October 2000 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between the ages of 18 and 70 with asthma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140946


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00140946     History of Changes
Other Study ID Numbers: 0476-075
MK0476-075
2005_057
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: January 22, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Budesonide
Montelukast
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action