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To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

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ClinicalTrials.gov Identifier: NCT00398151
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.

Condition or disease Intervention/treatment Phase
Asthma Drug: MK0476, montelukast sodium / Duration of Treatment: 12 Weeks Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
Actual Study Start Date : August 1, 2005
Primary Completion Date : January 18, 2006
Study Completion Date : January 18, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy

Secondary Outcome Measures :
  1. Asthma symptoms score throughout the study

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
  • Male or female outpatient 20 years of age and older
  • Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

Exclusion Criteria:

  • Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
  • Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
  • Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
  • Treated with montelukast within 3 months before enrollment
  • Unable to perform acceptable, reproducible spirometry and peak flow measurement
  • Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
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): NCT00398151

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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00398151     History of Changes
Other Study ID Numbers: 0476-366
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action