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Montelukast With Status Asthmaticus, Ages 6-18 | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Montelukast With Status Asthmaticus, Ages 6-18

Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment

NCT00494572•Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 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 who are in the PICU. The study will be stratified in 2 groups: children 6-12 years of age and adolescents 13-18 years of age. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Participants will be given a physical exam, have FEV1 measurements and clinical asthma scores recorded pre- and post- completion of a nebulized albuterol treatment of 0.1 mg/kg/dose (min 2.5 mg/dose). 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

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant's parent/legal guardian must give written informed consent and written assent must be obtained form the subject prior to study participation.
•1. Obtain consent of the parent/legal guardian using a signed consent form;
•2. Obtain assent form minors between the ages of 7-13 using a signed assent form;
•3. Obtain assent from minors between the ages of 14-17 by having the subject sign the consent formed signed the parent / legal guardian (Or based on the assessment by the Primary Investigator that the patient is unable to comprehend the study as written in the consent form document, the patient may document assent by signing the assent form).
•Participant, male or female, must be 6 to 18 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:
•1. Oxygen as needed
•2. \>3 nebulized albuterol treatments of at least 2.5mg/dose
+4 more criteria

Exclusion Criteria

•Known hypersensitivity to montelukast
•Chronic lung disease other than RAD or asthma
•Known renal disease
•Known hepatic disease
•Cardiac or pulmonary congenital anomalies
•Known immunologic disorders other than allergy and atopy
•Other explanations for respiratory distress
•Use of leukotriene modifiers within 2 weeks of the acute presentation
•Pregnant females
•Intubated patients
+1 more criteria

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 6-18

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma