Working... Menu

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)

Brief 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.

Condition or disease Intervention/treatment Phase
Status Asthmaticus Asthma Drug: Montelukast Other: sterile water Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment
Study Start Date : December 2006
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Montelukast

Arm Intervention/treatment
Sham Comparator: Sterile Water
Sterile water
Other: sterile water
sterile water

Active Comparator: Montelukast
10mg rapid dissolving granules in sterile water orally once
Drug: Montelukast
10 mg rapid dissolving granule in sterile water orally once

Primary Outcome Measures :
  1. Evaluate effectiveness of Montelukast as adjunctive therapy

Secondary Outcome Measures :
  1. Estimate the first dose pharmacokinetic parameter of Montelukast

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00494572

Layout table for location information
United States, Ohio
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Eloise Lemon, RN    216-844-3681   
Principal Investigator: Jeffrey Blumer, Ph.D., M.D.         
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric Pharmacology Research Units Network
Layout table for investigator information
Principal Investigator: Jeffrey Blumer, MD PPRU

Layout table for additonal information
Responsible Party: Jeffrey L. Blumer, Ph.D., M.D., University Hospitals Case Medical Center Identifier: NCT00494572     History of Changes
Other Study ID Numbers: PPRU 10856
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: December 16, 2008
Last Verified: November 2008

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Status Asthmaticus

Additional relevant MeSH terms:
Layout table for MeSH terms
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action