Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.

Phase 4

Completed

• Conditions: Asthma; Acute Asthma
• Interventions: Drug: montelukast 4 mg granule; Drug: Montelukast placebo granüle

• Registration Number: NCT01304901
• Lead Sponsor: Kecioren Education and Training Hospital

Brief Summary

The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.

Detailed Description

Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.

The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-17
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 6 months to 6 years of age
• With at least three episodes of wheezing in the previous 12 months
• Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13

Exclusion Criteria

• Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
• Who had any change in their dose of ICSs in the past 2 months
• Who had taken systemic corticosteroid within 1 months
• Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-Montelukast	montelukast 4 mg granule	Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
2- Placebo	Montelukast placebo granüle	Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Primary Outcome Measures

Name	Time	Method
Difference of pulmonary index score from baseline to 120 minutes.	0 to 120 minutes	İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.

Secondary Outcome Measures

Name	Time	Method
Proportion of discharge from emergency department.	120, 180 and 240. minutes	Proportion of subjects who were discharged from emergency department at 120,180 and 240. minutes were compared between the montelukast and placebo groups.

Trial Locations

Locations (1)

Kecioren Education and Training Hospital; 🇹🇷 Ankara, Keçiören, Turkey