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Montelukast With Status Asthmaticus, Ages 2-5

Primary Purpose

Status Asthmaticus, Asthma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Montelukast

Sterile water

About this trial

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

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rainbow Babies and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Montelukast

Arm Description

Sterile Water

Dissolved granules in sterile water

Outcomes

Primary Outcome Measures

Effectiveness of Montelukast as adjunctive therapy

Secondary Outcome Measures

Estimate the first dose pharmacokinetic parameters of Montelukast

Full Information

NCT ID

NCT00491790

First Posted

June 22, 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

1. Study Identification

Unique Protocol Identification Number

NCT00491790

Brief Title

Montelukast With Status Asthmaticus, Ages 2-5

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 2-5 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 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.

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

Arm Type

Sham Comparator

Arm Description

Sterile Water

Arm Title

Montelukast

Arm Type

Active Comparator

Arm Description

Dissolved granules in sterile water

Intervention Type

Drug

Intervention Name(s)

Montelukast

Intervention Description

Montelukast 4 mg rapid dissolving granules in sterile water given orally once

Intervention Type

Other

Intervention Name(s)

Sterile water

Intervention Description

Sterile water

Primary Outcome Measure Information:

Title

Effectiveness of Montelukast as adjunctive therapy

Secondary Outcome Measure Information:

Title

Estimate the first dose pharmacokinetic parameters of Montelukast

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey L. Blumer, M.D., Ph.D.

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

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 2-5

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