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Predicting the Response to Montelukast by Genetic Variation in Asthmatics

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. Identifier: NCT00116324
Recruitment Status : Completed
First Posted : June 29, 2005
Last Update Posted : April 4, 2007
Merck Sharp & Dohme Corp.
Information provided by:
Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Montelukast Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Predicting the Bronchoprotective Response to a Leukotriene Modifier by Genetic Polymorphism
Study Start Date : April 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Primary Outcome Measures :
  1. Change in hypertonic saline PD20

Secondary Outcome Measures :
  1. Improved asthma control
  2. Change in exhaled breath condensate inflammatory markers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00116324

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Merck Sharp & Dohme Corp.
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Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00116324    
Other Study ID Numbers: 2002-P-001696
First Posted: June 29, 2005    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007
Keywords provided by Brigham and Women's Hospital:
Leukotriene receptor antagonist
Hypertonic saline challenge
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System 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