Clinical trial NCT00565955: Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchial Asthma
Keywords: Montelukast
Acute Asthma
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2007-11-30
Enrollment: 116
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.
timeFrame: 4 hours
Secondary outcomes:
measure: Change in FEV1 at the end of 4 hours
timeFrame: 4 hours
measure: Adverse effects: Headache, nausea, vomiting, abdominal pain
timeFrame: 4 hours
measure: Need for hospitalization
timeFrame: 4 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: SUSHIL K KABRA
role: STUDY_DIRECTOR
References:
citation: Todi VK, Lodha R, Kabra SK. Effect of addition of single dose of oral montelukast to standard treatment in acute moderate to severe asthma in children between 5 and 15 years of age: a randomised, double-blind, placebo controlled trial. Arch Dis Child. 2010 Jul;95(7):540-3. doi: 10.1136/adc.2009.168567. Epub 2010 Jun 3.