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Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
HYPOTHESIS:
Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.
Leukotrienes plays an important role as mediator for inflammatory changes in acute as well as chronic asthma. There are three randomized controlled trials involving 274 adult patients with acute asthma who were treated with montelukast (intravenous in 2 and intravenous and oral in one study) to see the beneficial response in spirometry. All the studies showed significant improvement in FEV1 in first 2 hours. These studies show that oral montelukast causes improved pulmonary function and has a rapid onset of action. However, these studies are carried out in adults. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.
Therefore, we planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator | Children Between 5-15 Years of Age Receiving Montelukast |
|
| A2 | Placebo Comparator | Children Between 5-15 Years of Age Receiving Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast | Drug | Standard case management will be carried out as per guidelines given by British Thoracic Society. All patients will receive montelukast or similar looking placebo tablets. The doses of montelukast will be as follows: 5-12 years: 5 mg chewable tablet of montelukast; > 12 years: 10 mg chewable tablet of montelukast. Study drug will be administered at time of administration of steroid. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 at the end of 4 hours | 4 hours | |
| Adverse effects: Headache, nausea, vomiting, abdominal pain | 4 hours | |
| Need for hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SUSHIL K KABRA | All India Institute of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20522464 | Derived | Todi VK, Lodha R, Kabra SK. Effect of addition of single dose of oral montelukast to standard treatment in acute moderate to severe asthma in children between 5 and 15 years of age: a randomised, double-blind, placebo controlled trial. Arch Dis Child. 2010 Jul;95(7):540-3. doi: 10.1136/adc.2009.168567. Epub 2010 Jun 3. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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|
| Placebo | Drug | The patients will receive placebo tablets. |
|
| 4 hours |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |