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

Condition(s) targeted: Bronchial Asthma

Intervention: montelukast (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: All India Institute of Medical Sciences, New Delhi

Official(s) and/or principal investigator(s):
SUSHIL K KABRA, Study Director, Affiliation: All India Institute of Medical Sciences, New Delhi

Overall contact:
SUSHIL K KABRA, Phone: 91-9868397540, Email: skkabra@rediffmail.com

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, 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.

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.

Official title: Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.

Secondary outcome:

Change in FEV1 at the end of 4 hours

Adverse effects: Headache, nausea, vomiting, abdominal pain

Need for hospitalization

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.

Minimum age: 5 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

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.

SUSHIL K KABRA, Phone: 91-9868397540, Email: skkabra@rediffmail.com

All India Institute of Medical Sciences, NEW DELHI, DELHI, India; Recruiting

Starting date: March 2007
Ending date: June 2008
Last updated: May 19, 2008