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Montelukast With Status Asthmaticus, Ages 2-5

NCT ID: NCT00491790

Last Updated: 2008-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Status Asthmaticus Asthma

Keywords

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montelukast Albuterol Status Asthmaticus Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Sterile Water

Group Type SHAM_COMPARATOR

Sterile water

Intervention Type OTHER

Sterile water

Montelukast

Dissolved granules in sterile water

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

Montelukast 4 mg rapid dissolving granules in sterile water given orally once

Interventions

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Montelukast

Montelukast 4 mg rapid dissolving granules in sterile water given orally once

Intervention Type DRUG

Sterile water

Sterile water

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pediatric Pharmacology Research Units Network

NETWORK

Sponsor Role collaborator

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

NIH

Sponsor Role lead

Responsible Party

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University Hospitals Case Medical Center

Principal Investigators

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Jeffrey L. Blumer, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

PPRU

Locations

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Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Eloise Lemon, RN

Role: primary

Other Identifiers

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PPRU 10854

Identifier Type: -

Identifier Source: org_study_id