Status:
WITHDRAWN
Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Asthma; Status
Asthma in Children
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to standard treatment in children with moderate and severe acute exacerbations improves outcomes. Central Hypothes...
Detailed Description
Study overview: The approach to testing the central hypothesis will be to conduct a two-arm, parallel randomized controlled trial of high-dose (30mg) montelukast versus identical placebo, as add-on to...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 5 to 17 years, inclusive
- Parental report of asthma diagnosis by a health care provider
- At least one previous wheezing episode treated with albuterol
- Moderate or severe acute asthma exacerbation measured using the validated AAIRS bedside asthma severity score
- Exclusion criteria:
- Prior study enrollment
- Chronic lung disease other than asthma
- History of prematurity less than 34 weeks gestational age
- Acute or chronic liver disease
- Presence of tracheostomy
- Use of noninvasive ventilation at home
- Need for immediate airway intervention (e.g., endotracheal intubation or noninvasive ventilation)
- Allergy to montelukast
- Pregnancy
- Tuberculosis
- Gastroesophageal reflux requiring acid-blocking medication; and
- Prior use of an LTRA (e.g., montelukast)
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03277170
Start Date
September 1 2025
End Date
September 5 2029
Last Update
November 18 2024
Active Locations (1)
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1
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232