Montelukast With Status Asthmaticus, Ages 2-5

United States Department of Health and Human Services (HHS)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Asthma; Status Asthmaticus

Treatments: Other: Sterile water; Drug: Montelukast

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00491790

PPRU 10854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

1

Sham Comparator group

Description:

Sterile Water

Treatment:

Other: Sterile water

Montelukast

Active Comparator group

Description:

Dissolved granules in sterile water

Treatment:

Drug: Montelukast