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

Kecioren Education and Training Hospital

Status and phase: Completed; Phase 4

Conditions: Acute Wheezy Bronchitis; Acute Asthma

Treatments: Drug: Placebos; Drug: Montelukast 4 Mg Oral Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT03369119

B.10.0.İEG.0.11.00.01/003247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 6 to 60 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Montelukast

Active Comparator group

Description:

Children received 4 mg oral montelukast granule daily until discharge.

Treatment:

Drug: Montelukast 4 Mg Oral Granule

Placebo

Placebo Comparator group

Description:

Children receive 4 mg oral placebo montelukast granule daily until discharge

Treatment:

Drug: Placebos