Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children

Phase 3

Completed

• Conditions: Bronchial Asthma
• Interventions: Drug: Placebo; Drug: montelukast

• Registration Number: NCT00565955
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Study First Posted: 2007-11-30
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-13
• Last Update Posted: 2008-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Placebo	Children Between 5-15 Years of Age Receiving Placebo
A1	montelukast	Children Between 5-15 Years of Age Receiving Montelukast

Primary Outcome Measures

Name	Time	Method
Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.	4 hours

Secondary Outcome Measures

Name	Time	Method
Change in FEV1 at the end of 4 hours	4 hours
Adverse effects: Headache, nausea, vomiting, abdominal pain	4 hours
Need for hospitalization	4 hours

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India