Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
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.
Inclusion Criteria:

 -  Children aged 5-15 years of age, either sex seeking treatment with acute moderate to
 severe asthma in pediatric casualty/ chest clinic/ out patient services. Acute
 moderate to severe asthma is defined as modified pulmonary index score of more than 9.

 Exclusion Criteria:

 -  Children with life threatening asthma (poor respiratory efforts, cyanosis, altered
 sensorium).

 -  Children who had received montelukast within one week of arrival.

 -  Children with other chronic respiratory conditions (including congenital lung
 abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would
 complicate current treatment and response for asthma.

 -  Children with altered sensorium/unable to take oral medication.