Montelukast With Status Asthmaticus, Ages 2-5
Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Status Asthmaticus; Asthma
Intervention: Montelukast (Drug); Sterile water (Other)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Jeffrey L. Blumer, M.D., Ph.D., Principal Investigator, Affiliation: PPRU
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.
Clinical Details
Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Effectiveness of Montelukast as adjunctive therapy
Secondary outcome: Estimate the first dose pharmacokinetic parameters of Montelukast
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
Minimum age: 2 Years.
Maximum age: 5 Years.
Gender(s): Both.
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
Locations and Contacts
Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States; Recruiting
Eloise Lemon, RN, Phone: 216-844-3681, Email: eloise.lemon@uhhs.com
Jeffrey Blumer, Ph.D., M.D., Principal Investigator
Additional Information
Starting date: December 2006
Ending date: October 2010
Last updated: December 15, 2008
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