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

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00565955
First received: November 29, 2007
Last updated: November 13, 2008
Last verified: November 2008

November 29, 2007
November 13, 2008
March 2007
October 2008   (final data collection date for primary outcome measure)
Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00565955 on ClinicalTrials.gov Archive Site
  • Change in FEV1 at the end of 4 hours [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Adverse effects: Headache, nausea, vomiting, abdominal pain [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Need for hospitalization [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
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, 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bronchial Asthma
  • 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.
  • Active Comparator: A1
    Children Between 5-15 Years of Age Receiving Montelukast
    Intervention: Drug: montelukast
  • Placebo Comparator: A2
    Children Between 5-15 Years of Age Receiving Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
5 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00565955
vivek
Yes
VIVEK KUMAR TODI, All India Institute of Medical Sciences
All India Institute of Medical Sciences, New Delhi
Not Provided
Study Director: SUSHIL K KABRA All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP