Effect of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children - Full Text View

Sponsor:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00565955

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Nausea and Vomiting

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

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 ]

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 ]

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
A1: Active Comparator 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.
A2: Placebo Comparator Children Between 5-15 Years of Age Receiving Placebo	Drug: Placebo The patients will receive placebo tablets.

Arms

Assigned Interventions

A1: Active Comparator

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.

A2: Placebo Comparator

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565955

Locations

India, DELHI
All India Institute of Medical Sciences
NEW DELHI, DELHI, India

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

Study Director:

SUSHIL K KABRA

All India Institute of Medical Sciences, New Delhi

More Information

No publications provided

Responsible Party:	All India Institute of Medical Sciences ( VIVEK KUMAR TODI )
Study ID Numbers:	vivek
Study First Received:	November 29, 2007
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00565955 History of Changes
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:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010