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To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00398151
First received: November 9, 2006
Last updated: February 2, 2007
Last verified: February 2007
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

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

Secondary Outcome Measures:
  • Asthma symptoms score throughout the study

Estimated Enrollment: 50
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergic rhinints 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398151

Locations
Taiwan
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00398151     History of Changes
Other Study ID Numbers: 2006_043
Study First Received: November 9, 2006
Last Updated: February 2, 2007
Health Authority: Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:
Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
 Respiratory Tract Infections
Otorhinolaryngologic Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013