Status:
COMPLETED
Predicting the Response to Montelukast by Genetic Variation in Asthmatics
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 hypot...
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00116324
Start Date
April 1 2003
End Date
December 1 2006
Last Update
May 18 2021
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115