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Montelukast With Status Asthmaticus, Ages 2-5 | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Montelukast With Status Asthmaticus, Ages 2-5

NCT00491790•Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Summary

The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 2-5 who are in the hospital because of status asthmaticus.

Detailed Description

This is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children from 2-5 years old who are in the PICU. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Once enrolled, a baseline modified Wood's-Downes clinical asthma severity score will be recorded pre and post completion of a standard nebulized albuterol treatment of 0.15 mg/kg/dose (min2.5mg/dose). Patients who are able will have FEV1 measurements obtained at predetermined intervals for determination of clinical asthma severity score. Blood samples for PK analysis will be collected prior to study drug administration and at predetermined time intervals to determine the plasma level of montelukast. In addition, a blood sample will be obtained for genetic study of polymorphisms of CYP3A4, CYP3A5, and CYP2C9.

Eligibility

Age

2 - 5 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant's parent/legal guardian must give written informed consent prior to study participation. When appropriate, written assent from the child will also be obtained.
•Participant, male or female, must be 2 to 5 years of age.
•Participant must have a history of reactive airway disease (RAD) or asthma, and must currently be admitted for an acute exacerbation of RAD or asthma.
•Primary physician must believe that patient would benefit from improved bronchodilation and improvement in clinical asthma severity score.
•Participant must have received standard therapy for status asthmaticus: Oxygen as needed; 3 nebulized albuterol treatments of at least 2.5mg/dose; Methylprednisolone or prednisone loading dose of 2mg/kg; Ongoing methylprednisolone therapy @ 0.5mg/kg every 6

Exclusion Criteria

•Known hypersensitivity to montelukast
•Chronic lung disease
•Cardiac or pulmonary congenital anomalies
•Known renal disease
•Known hepatic disease
•Known immunologic disorders other than allergy and atopy
•Other explanations for respiratory distress
•Use of leukotriene modifiers within 2 weeks of the acute presentation
•Intubated patients

Locations (1)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

January 1, 2010

Completion Date

October 1, 2010

Last Updated

December 16, 2008

Enrollment

ESTIMATED participants

Conditions

Status AsthmaticusAsthma

Interventions

Montelukast

DRUG

Sterile water

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Montelukast With Status Asthmaticus, Ages 2-5

Inclusion Criteria

Exclusion Criteria

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