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Predicting the Response to Montelukast by Genetic Variation in Asthmatics

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00116324
First received: June 28, 2005
Last updated: April 2, 2007
Last verified: April 2007
History of Changes
  Purpose

The purpose of this study is to examine a specific variation in the genetic code for an enzyme (LTC4 synthase) which plays an important role in the airway inflammation associated with asthma. We hypothesize that asthmatic patients with this variant gene will have a better response to montelukast than patients with the wild type gene, as measured by the ability of montelukast to protect against a hypertonic saline challenge.


Condition Intervention Phase
Asthma
 Drug: Montelukast
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Predicting the Bronchoprotective Response to a Leukotriene Modifier by Genetic Polymorphism

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in hypertonic saline PD20

Secondary Outcome Measures:
  • Improved asthma control
  • Change in exhaled breath condensate inflammatory markers

Estimated Enrollment: 150
Study Start Date: April 2003
Study Completion Date: December 2006
Detailed Description:

Multiple genetic polymorphisms in the leukotriene pathway have been described but their clinical relevance is unclear. A single nucleotide polymorphism in the LTC4 synthase promoter region has been associated with increased LTC4 synthase mRNA and a trend toward improved bronchodilatory response to leukotriene modifiers in severe asthmatics. This study will examine mild to moderate asthmatics with the variant gene and evaluate the bronchoprotective response of montelukast in a double-blind, placebo-controlled cross-over fashion.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects, age 18-55
  • Clinical history consistent with asthma
  • Mild to moderate asthma as determined by pulmonary function tests--60% or higher of predicted FEV1 for age, sex and race.
  • Response to hypertonic saline, which will be the main outcome variable measured.

Exclusion Criteria:

  • Smokers (total lifetime smoking history>10 pack-years, any in the past year)
  • Pregnant woman—if of childbearing age, not using an acceptable form of birth control.
  • Use of a leukotriene modifier within the past month
  • Use of inhaled or oral steroids within the past month.
  • Emergency room visit for asthma exacerbation within the past 6 weeks.
  • Intubation for asthma exacerbation in the past 10 years.
  • Adverse reaction to inhaled beta-agonists in the past.
  • No recent (past 48 hours) use of anticholinergics, theophylline, antihistamines, pseudoephedrine.
  • Patients will also be asked not to use any short acting beta-agonists for 6 hours and long-acting beta-agonists for 48 hours before their initial visit (when pulmonary function evaluation will be performed).
  • Lung disease other than asthma
  • Significant medical illness other than asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116324

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Merck
Investigators
Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00116324     History of Changes
Other Study ID Numbers: 2002-P-001696
Study First Received: June 28, 2005
Last Updated: April 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Asthma
Leukotriene receptor antagonist
Hypertonic saline challenge

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System 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 19, 2013