Phase 4 Study of Oral Montelukast Hospitalized Preschool Children
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
Study Overview
Brief Summary
Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations.
The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.
Detailed Description
Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.
Objective
To evaluate the effect of the addition of a single dose of oral montelukast to standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel group trial. Setting: Pediatric service of Education and training Hospital Patients: Children with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical asthma score was recorded before administering study medication and thereafter, 4 hourly until discharge. Main outcome measure: The primary outcome was discharge rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Months to 60 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Medical history of at least 4 wheezing attacks
- •Children with the ages of 6-60 months
- •Children whose parents accept to give written informed consent
Exclusion Criteria
- •Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)
- •Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)
Arms & Interventions
Montelukast
Children received 4 mg oral montelukast granule daily until discharge.
Intervention: Montelukast 4 Mg Oral Granule (Drug)
Placebo
Children receive 4 mg oral placebo montelukast granule daily until discharge
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
Length of hospital stay
Time Frame: within the 5 days from hospitalization
The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.
Secondary Outcomes
- Difference in clinical asthma score(Within 72 hours from hospitalization)
Investigators
Cem Hasan Razi
Pediatric Allergy Specialist
Kecioren Education and Training Hospital