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)

June 22, 2007
June 26, 2007
December 16, 2008
December 2006
January 2010   (Final data collection date for primary outcome measure)
Effectiveness of Montelukast as adjunctive therapy
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Complete list of historical versions of study NCT00491790 on Archive Site
Estimate the first dose pharmacokinetic parameters of Montelukast
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Montelukast With Status Asthmaticus, Ages 2-5
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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.
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.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Status Asthmaticus
  • Asthma
  • Drug: Montelukast
    Montelukast 4 mg rapid dissolving granules in sterile water given orally once
  • Other: Sterile water
    Sterile water
  • Sham Comparator: 1
    Sterile Water
    Intervention: Other: Sterile water
  • Active Comparator: Montelukast
    Dissolved granules in sterile water
    Intervention: Drug: Montelukast
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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October 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 5 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
PPRU 10854
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Jeffrey L. Blumer, Ph.D, M.D., University Hospitals Case Medical Center
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP