Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children

Acute Asthma Clinical Trial

Official title:

Phase 4 Study of Oral Montelukast Hospitalized Preschool Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369119
• Other study ID #: B.10.0.IEG.0.11.00.01/003247
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2017
• Last updated: December 5, 2017
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2017
• Source: Kecioren Education and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations.

The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.

Description:

Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.

Objective: To evaluate the effect of the addition of a single dose of oral montelukast to standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel group trial. Setting: Pediatric service of Education and training Hospital Patients: Children with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical asthma score was recorded before administering study medication and thereafter, 4 hourly until discharge. Main outcome measure: The primary outcome was discharge rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 60 Months

Eligibility

Inclusion Criteria:

• Medical history of at least 4 wheezing attacks

• Children with the ages of 6-60 months

• Children whose parents accept to give written informed consent

Exclusion Criteria:

• Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)

• Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)

Related Conditions & MeSH terms

• Acute Asthma
• Acute Wheezy Bronchitis
• Asthma
• Bronchiolitis
• Bronchitis

Intervention

Drug:
• Montelukast 4 Mg Oral Granule

• Placebos

Locations

Country	Name	City	State
Turkey	Kecioren Education and Training Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.	within the 5 days from hospitalization
Secondary	Difference in clinical asthma score	Improvement of clinical asthma scores between the 2 groups within 72 hours	Within 72 hours from hospitalization