Montelukast With Status Asthmaticus, Ages 2-5

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491790
Recruitment Status : Unknown
Verified November 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : June 26, 2007
Last Update Posted : December 16, 2008
Pediatric Pharmacology Research Units Network
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Condition or disease Intervention/treatment Phase
Status Asthmaticus Asthma Drug: Montelukast Other: Sterile water Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : December 2006
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

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

Primary Outcome Measures :
  1. Effectiveness of Montelukast as adjunctive therapy

Secondary Outcome Measures :
  1. Estimate the first dose pharmacokinetic parameters of Montelukast

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491790

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

Responsible Party: Jeffrey L. Blumer, Ph.D, M.D., University Hospitals Case Medical Center Identifier: NCT00491790     History of Changes
Other Study ID Numbers: PPRU 10854
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: December 16, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action