Predicting the Response to Montelukast by Genetic Variati... | NCT00116324

Studies
Predicting the Response to Montelukast by Genetic Variation in Asthmatics

NCT00116324

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

May 18, 2021Actual

Enrollment

150

Phase

Phase 3

Conditions

Asthma

Interventions

Montelukast

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Jun 28, 2005

First Submission Date that Met QC Criteria

Jun 28, 2005

First Posted Date

Jun 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2021

Last Update Posted Date

May 18, 2021Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Montelukast	Drug

Measure	Description	Time Frame
Change in hypertonic saline PD20

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Elliot Israel, MD	Brigham and Women's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1320817	Background	Drazen JM, O'Brien J, Sparrow D, Weiss ST, Martins MA, Israel E, Fanta CH. Recovery of leukotriene E4 from the urine of patients with airway obstruction. Am Rev Respir Dis. 1992 Jul;146(1):104-8. doi: 10.1164/ajrccm/146.1.104.
2564113	Background	Taylor GW, Taylor I, Black P, Maltby NH, Turner N, Fuller RW, Dollery CT. Urinary leukotriene E4 after antigen challenge and in acute asthma and allergic rhinitis. Lancet. 1989 Mar 18;1(8638):584-8. doi: 10.1016/s0140-6736(89)91611-5.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Measure	Description	Time Frame
Improved asthma control
Change in exhaled breath condensate inflammatory markers