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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Bronchial Asthma
Intervention	Drug: montelukast Drug: Placebo
Phase	Phase 3
Sponsor	All India Institute of Medical Sciences, New Delhi
Responsible Party	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

Tracking Information[ + expand ][ + ]

First Received Date	November 29, 2007
Last Updated Date	November 13, 2008
Start Date	March 2007
Estimated Primary Completion Date	October 2008
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	116
Estimated Completion Date	October 2008
Estimated Primary Completion Date	October 2008
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.
Gender	Both
Ages	5 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT00565955
Other Study ID Numbers	vivek
Has Data Monitoring Committee	Yes
Information Provided By	All India Institute of Medical Sciences, New Delhi
Study Sponsor	All India Institute of Medical Sciences, New Delhi
Collaborators	Not Provided
Investigators	Study Director: SUSHIL K KABRA All India Institute of Medical Sciences, New Delhi
Verification Date	November 2008

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