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The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.
Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.
The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Montelukast | Active Comparator | Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids. |
|
| 2- Placebo | Placebo Comparator | Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast 4 mg granule | Drug | Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of pulmonary index score from baseline to 120 minutes. | İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups. | 0 to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of discharge from emergency department. | Proportion of subjects who were discharged from emergency department at 120,180 and 240. minutes were compared between the montelukast and placebo groups. | 120, 180 and 240. minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CEM H RAZİ, M.D. | Kecioren Education and Training Hospital | Study Director |
| ELİF YAĞLI ÇOLAKOĞLU, M.D. | Kecioren Education and Training Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kecioren Education and Training Hospital | Ankara | Keçiören | 06290 | Turkey (Türkiye) |
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| Montelukast placebo granüle | Drug | Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids. |
|
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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