Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi