Montelukast With Status Asthmaticus, Ages 6-18

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: NCT00494572
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 29, 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 28, 2007
June 29, 2007
December 16, 2008
December 2006
January 2010   (Final data collection date for primary outcome measure)
Evaluate effectiveness of Montelukast as adjunctive therapy
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Complete list of historical versions of study NCT00494572 on Archive Site
Estimate the first dose pharmacokinetic parameter of Montelukast
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Montelukast With Status Asthmaticus, Ages 6-18
Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment
The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 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 who are in the PICU. The study will be stratified in 2 groups: children 6-12 years of age and adolescents 13-18 years of age. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Participants will be given a physical exam, have FEV1 measurements and clinical asthma scores recorded pre- and post- completion of a nebulized albuterol treatment of 0.1 mg/kg/dose (min 2.5 mg/dose). 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
    10 mg rapid dissolving granule in sterile water orally once
  • Other: sterile water
    sterile water
  • Sham Comparator: Sterile Water
    Sterile water
    Intervention: Other: sterile water
  • Active Comparator: Montelukast
    10mg rapid dissolving granules in sterile water orally once
    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
Not Provided
October 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant's parent/legal guardian must give written informed consent and written assent must be obtained form the subject prior to study participation.

    1. Obtain consent of the parent/legal guardian using a signed consent form;
    2. Obtain assent form minors between the ages of 7-13 using a signed assent form;
    3. Obtain assent from minors between the ages of 14-17 by having the subject sign the consent formed signed the parent / legal guardian (Or based on the assessment by the Primary Investigator that the patient is unable to comprehend the study as written in the consent form document, the patient may document assent by signing the assent form).
  • Participant, male or female, must be 6 to 18 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:

    1. Oxygen as needed
    2. >3 nebulized albuterol treatments of at least 2.5mg/dose
    3. Methylprednisolone or prednisone loading dose of 2mg/kg
    4. Ongoing methylprednisolone therapy @ 0.5mg/kg every 6 hours
  • Participant must have received steroids at least 6 hours prior to their inclusion, and must still require nebulized albuterol at least every 2 hours, as determined by PICU team in accordance with the PICU standard for evaluating and treating patients with RAD or asthma exacerbations.
  • Participant must have an indwelling catheter in place from which to obtain blood specimens. Catheter may be peripheral or central, arterial or venous.

Exclusion Criteria:

  • Known hypersensitivity to montelukast
  • Chronic lung disease other than RAD or asthma
  • Known renal disease
  • Known hepatic disease
  • Cardiac or pulmonary congenital anomalies
  • Known immunologic disorders other than allergy and atopy
  • Other explanations for respiratory distress
  • Use of leukotriene modifiers within 2 weeks of the acute presentation
  • Pregnant females
  • Intubated patients
  • Inability to participate in portable spirometry for FEV1 measurement
Sexes Eligible for Study: All
6 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
PPRU 10856
Not Provided
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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 Blumer, MD 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