Montelukast With Status Asthmaticus, Ages 2-5

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Recruitment status was Recruiting

First Received on June 22, 2007. Last Updated on December 15, 2008 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Pediatric Pharmacology Research Units Network
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00491790

Purpose

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.

Condition	Intervention	Phase
Status Asthmaticus Asthma	Drug: Montelukast Other: Sterile water	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Effectiveness of Montelukast as adjunctive therapy

Secondary Outcome Measures:

Estimate the first dose pharmacokinetic parameters of Montelukast

Estimated Enrollment:	52
Study Start Date:	December 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	2 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491790

Locations

United States, Ohio
Rainbow Babies and Children's Hospital	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Eloise Lemon, RN 216-844-3681 eloise.lemon@uhhs.com
Principal Investigator: Jeffrey Blumer, Ph.D., M.D.

Sponsors and Collaborators

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

Pediatric Pharmacology Research Units Network

Investigators

Principal Investigator:

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

PPRU

More Information

No publications provided

Responsible Party:	Jeffrey L. Blumer, Ph.D, M.D., University Hospitals Case Medical Center
ClinicalTrials.gov Identifier:	NCT00491790 History of Changes
Other Study ID Numbers:	PPRU 10854
Study First Received:	June 22, 2007
Last Updated:	December 15, 2008
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

montelukast
Albuterol
Status Asthmaticus
Asthma

Additional relevant MeSH terms:

Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012