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Leukotriene Polymorphisms and Montelukast Response - Ancillary to LoDo Trial

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: NCT00046644
Recruitment Status : Completed
First Posted : October 1, 2002
Last Update Posted : April 17, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Nemours Children's Clinic

Brief Summary:
To elucidate the mechanisms underlying inter-patient variation in response to montelukast, a drug for asthma.

Condition or disease
Asthma Lung Diseases

Detailed Description:


Asthma is a common disease caused by a complex interaction between genetic and environmental factors. Asthma afflicts 17 million Americans. In 1999, more than 5000 persons died from asthma. Given the significant mortality and morbidity associated with asthma, it is important to continue to develop new strategies for intervention. Leukotriene antagonists are thought to be the most innovative approach to asthma therapy in 20 years. Despite their demonstrated efficacy, safety and popularity, the leukotriene antagonists are associated with a significant degree of inter-patient variability in response, which can limit their safety, efficacy and cost-effectiveness. Several polymorphisms in leukotriene pathway genes can contribute to variability in response. The project will determine if polymorphisms in genes encoding 5-lipoxygenase, leukotriene A4hydrolase, LTC4 synthase, multi-drug resistance protein 1 (MRP1) and LT1 receptor proteins are determinants of response to montelukast treatment.

The study is in response to an Request for Applications entitled Ancillary Studies in Heart, Lung, and Blood Disease Trials which was released by the NHLBI in June 2000 to conduct mechanistic studies in clinical trials related to heart, lung and blood diseases. Specifically, this initiative focuses on the utilization of patients and patient materials from such trials to study the mechanisms underlying the interventions, the mechanisms of disease pathogenesis, surrogate markers or biomarkers of disease activity and therapeutic effect and the mechanisms of human cardiopulmonary and hematologic function. Studies aimed at accelerating the development of new technologies within the context of the mechanistic investigations are also encouraged.


DNA will be collected from patients participating in a parent clinical trial entitled: Effectiveness of Low Dose Theophylline as Add-On Therapy in the Treatment of Asthma (LoDo Trial). 627 patients from 19 Asthma Clinical Research Centers will be randomly assigned to receive placebo, or low dose theophylline (300 mg/day) or montelukast, 10 mg daily, for 6 months. Stepwise Linear and Poisson regressions will be performed on outcomes including treatment and genetic covariates, and interaction terms between treatment arm and genetic makeup. Polymorphisms that are highly associated with response can lead to the development of genetic tests that will identify patients most likely to benefit from montelukast treatment. This information may lead to individualization of asthma medications based on the genetic make-up of the patient.

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Study Type : Observational
Study Start Date : June 2002
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria

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): NCT00046644

Sponsors and Collaborators
Nemours Children's Clinic
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: John Lima Nemours Children's Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00046644    
Other Study ID Numbers: 1189
R01HL071394 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2002    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases