Montelukast With Status Asthmaticus, Ages 2-5

Asthma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00491790
• Other study ID #: PPRU 10854
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 22, 2007
• Last updated: December 15, 2008
• Start date: December 2006
• Est. completion date: October 2010

Study information

• Verified date: November 2008
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: October 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Status Asthmaticus

Intervention

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

Other:
• Sterile water
Sterile water

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Montelukast as adjunctive therapy
Secondary	Estimate the first dose pharmacokinetic parameters of Montelukast