Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children (Montelukast)
|ClinicalTrials.gov Identifier: NCT00565955|
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : November 14, 2008
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.
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 or disease||Intervention/treatment||Phase|
|Bronchial Asthma||Drug: montelukast Drug: Placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||March 2007|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
Active Comparator: A1
Children Between 5-15 Years of Age Receiving 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.
Placebo Comparator: A2
Children Between 5-15 Years of Age Receiving Placebo
The patients will receive placebo tablets.
- Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. [ Time Frame: 4 hours ]
- Change in FEV1 at the end of 4 hours [ Time Frame: 4 hours ]
- Adverse effects: Headache, nausea, vomiting, abdominal pain [ Time Frame: 4 hours ]
- Need for hospitalization [ Time Frame: 4 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565955
|All India Institute of Medical Sciences|
|New Delhi, Delhi, India|
|Study Director:||SUSHIL K KABRA||All India Institute of Medical Sciences, New Delhi|