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Montelukast With Status Asthmaticus, Ages 6-18

Primary Purpose

Status Asthmaticus, Asthma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Montelukast
sterile water
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Asthmaticus focused on measuring Montelukast, Albuterol, Status Asthmaticus, Asthma

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rainbow Babies and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sterile Water

Montelukast

Arm Description

Sterile water

10mg rapid dissolving granules in sterile water orally once

Outcomes

Primary Outcome Measures

Evaluate effectiveness of Montelukast as adjunctive therapy

Secondary Outcome Measures

Estimate the first dose pharmacokinetic parameter of Montelukast

Full Information

First Posted
June 28, 2007
Last Updated
December 15, 2008
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Pediatric Pharmacology Research Units Network
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1. Study Identification

Unique Protocol Identification Number
NCT00494572
Brief Title
Montelukast With Status Asthmaticus, Ages 6-18
Official Title
Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Pediatric Pharmacology Research Units Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Asthmaticus, Asthma
Keywords
Montelukast, Albuterol, Status Asthmaticus, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sterile Water
Arm Type
Sham Comparator
Arm Description
Sterile water
Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
10mg rapid dissolving granules in sterile water orally once
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
10 mg rapid dissolving granule in sterile water orally once
Intervention Type
Other
Intervention Name(s)
sterile water
Intervention Description
sterile water
Primary Outcome Measure Information:
Title
Evaluate effectiveness of Montelukast as adjunctive therapy
Secondary Outcome Measure Information:
Title
Estimate the first dose pharmacokinetic parameter of Montelukast

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. Obtain consent of the parent/legal guardian using a signed consent form; Obtain assent form minors between the ages of 7-13 using a signed assent form; 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Blumer, MD
Organizational Affiliation
PPRU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eloise Lemon, RN
Phone
216-844-3681
Email
eloise.lemon@uhhs.com
First Name & Middle Initial & Last Name & Degree
Jeffrey Blumer, Ph.D., M.D.

12. IPD Sharing Statement

Learn more about this trial

Montelukast With Status Asthmaticus, Ages 6-18

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