A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00157937
First received: September 7, 2005
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.


Condition Intervention Phase
Asthma
Allergic Rhinitis
Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks
Drug: Comparator: theophylline ER/Duration of Treatment: 16 weeks
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics

Resource links provided by NLM:


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

Primary Outcome Measures:
  • FEV1

Secondary Outcome Measures:
  • AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA

Estimated Enrollment: 68
Study Start Date: May 2003
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between the ages of 18 and 60 with mild to moderate asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157937

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157937     History of Changes
Other Study ID Numbers: 0476-329, 2005_069
Study First Received: September 7, 2005
Last Updated: May 5, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014