Montelukast With Status Asthmaticus, Ages 2-5

December 15, 2008 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey Blumer, Ph.D., M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 1
Sterile Water
Other: Sterile water
Sterile water
Active Comparator: Montelukast
Dissolved granules in sterile water
Drug: Montelukast
Montelukast 4 mg rapid dissolving granules in sterile water given orally once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effectiveness of Montelukast as adjunctive therapy

Secondary Outcome Measures

Outcome Measure
Estimate the first dose pharmacokinetic parameters of Montelukast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Pediatric Pharmacology Research Units Network

Investigators

  • Principal Investigator: Jeffrey L. Blumer, M.D., Ph.D., PPRU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

June 22, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (Estimate)

June 26, 2007

Study Record Updates

Last Update Posted (Estimate)

December 16, 2008

Last Update Submitted That Met QC Criteria

December 15, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPRU 10854

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Sterile water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe