Montelukast With Status Asthmaticus, Ages 6-18
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 Blumer, MD, 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 6-18 who are in the hospital because of status
asthmaticus.
Clinical Details
Official title: Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment
Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Evaluate effectiveness of Montelukast as adjunctive therapy
Secondary outcome: Estimate the first dose pharmacokinetic parameter of Montelukast
Detailed description:
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.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
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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