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”

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.

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: montelukast
  • 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.
• Drug: Placebo
  • The patients will receive placebo tablets.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A1
  • Children Between 5-15 Years of Age Receiving Montelukast
• Placebo Comparator: A2
  • Children Between 5-15 Years of Age Receiving Placebo

Primary Measures

• Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.
  • Time Frame: 4 hours
    Safety Issue?: No

Secondary Measures

• Change in FEV1 at the end of 4 hours
  • Time Frame: 4 hours
    Safety Issue?: No
• Adverse effects: Headache, nausea, vomiting, abdominal pain
  • Time Frame: 4 hours
    Safety Issue?: No
• Need for hospitalization
  • Time Frame: 4 hours
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 15 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Overall Clinical Trial Officials and Contacts

SUSHIL K KABRA Study Director All India Institute of Medical Sciences, New Delhi  

Overall Contact: SUSHIL K KABRA 91-9868397540 skkabra@rediffmail.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565955

Study ID Number: vivek

ClinicalTrials.gov Identifier: NCT00565955

Health Authority: India: Drugs Controller General of India