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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Active Comparator | Children received 4 mg oral montelukast granule daily until discharge. |
|
| Placebo | Placebo Comparator | Children receive 4 mg oral placebo montelukast granule daily until discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast 4 Mg Oral Granule | Drug |
|
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups. | within the 5 days from hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in clinical asthma score | Improvement of clinical asthma scores between the 2 groups within 72 hours | Within 72 hours from hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cem H. Razi, M.D. | Pediatric Allergy Specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kecioren Education and Training Hospital | Ankara | Keçiören | 06380 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Drug |
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