Montelukast With Status Asthmaticus, Ages 2-5

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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