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

NCT00565955 | Completed Phase 3 DMC

• 1 other identifier: vivek
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma

Keywords

Montelukast; Acute Asthma

Outcome Measures

Primary Outcomes (1)

• Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours.

  4 hours

Secondary Outcomes (3)

• Change in FEV1 at the end of 4 hours

  4 hours

• Adverse effects: Headache, nausea, vomiting, abdominal pain

  4 hours

• Need for hospitalization

  4 hours

Study Arms (2)

A1

ACTIVE COMPARATOR

Children Between 5-15 Years of Age Receiving Montelukast

Drug: montelukast

A2

PLACEBO COMPARATOR

Children Between 5-15 Years of Age Receiving Placebo

Drug: Placebo

Interventions

montelukast DRUG

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.

A1

Placebo DRUG

The patients will receive placebo tablets.

A2

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Location

Related Publications (1)

• 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.

  PMID: 20522464 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• SUSHIL K KABRA

  All India Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 14, 2008

Record last verified: 2008-11

Locations

IN (1)