Montelukast With Status Asthmaticus, Ages 2-5
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Status Asthmaticus, Asthma
In brief
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.
Key facts
- Study ID
- NCT00491790
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 52
- Starts
- 2006-12-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2008-12-16
Who can join
Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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