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Montelukast With Status Asthmaticus, Ages 6-18

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
Pediatric Pharmacology Research Units Network
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: June 28, 2007
Last updated: December 15, 2008
Last verified: November 2008
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 Intervention Phase
Status Asthmaticus Asthma Drug: Montelukast Other: sterile water Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Evaluate effectiveness of Montelukast as adjunctive therapy

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

Estimated Enrollment: 52
Study Start Date: December 2006
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00494572

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
Principal Investigator: Jeffrey Blumer, MD PPRU
  More 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
Study First Received: June 28, 2007
Last Updated: December 15, 2008

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

Additional relevant 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 processed this record on September 21, 2017