Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children
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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 | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma |
Drug: montelukast Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- 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 ]
- 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 ]
| Enrollment: | 116 |
| Study Start Date: | March 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A1
Children Between 5-15 Years of Age Receiving Montelukast
|
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. |
|
Placebo Comparator: A2
Children Between 5-15 Years of Age Receiving Placebo
|
Drug: Placebo
The patients will receive placebo tablets.
|
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| Ages Eligible for Study: | 5 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| India | |
| All India Institute of Medical Sciences | |
| New Delhi, Delhi, India | |
| Study Director: | SUSHIL K KABRA | All India Institute of Medical Sciences, New Delhi |
More Information
No publications provided by All India Institute of Medical Sciences, New Delhi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VIVEK KUMAR TODI, All India Institute of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00565955 History of Changes |
| Other Study ID Numbers: | vivek |
| Study First Received: | November 29, 2007 |
| Last Updated: | November 13, 2008 |
| Health Authority: | India: Drugs Controller General of India |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
Montelukast Acute Asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013