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Completed

NCT Number: NCT00565955

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.

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Montelukast

Drug

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.

Placebo

Drug

The patients will receive placebo tablets.

Primary outcomes

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

    Time frame: 4 hours

Secondary outcomes

  1. Change in FEV1 at the end of 4 hours

    Time frame: 4 hours

  2. Adverse effects: Headache, nausea, vomiting, abdominal pain

    Time frame: 4 hours

  3. Need for hospitalization

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study 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

Acronym: Montelukast

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2007
Registry last updated
Nov 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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