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
Sponsor:
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
First received: June 22, 2007
Last updated: December 15, 2008
Last verified: November 2008

June 22, 2007
December 15, 2008
December 2006
January 2010   (final data collection date for primary outcome measure)
Effectiveness of Montelukast as adjunctive therapy
Not Provided
Complete list of historical versions of study NCT00491790 on ClinicalTrials.gov Archive Site
Estimate the first dose pharmacokinetic parameters of Montelukast
Not Provided
Not Provided
Not Provided
 
Montelukast With Status Asthmaticus, Ages 2-5
Not Provided

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
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
Both
2 Years to 5 Years
No
Not Provided
United States
 
NCT00491790
PPRU 10854
Yes
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