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OpenTrials
Completed

NCT Number: NCT03369119

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

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.

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Key information

Conditions

Acute Asthma Acute Wheezy Bronchitis

Age range

6 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kecioren Education and Training Hospital

Ankara, Keçiören, 06380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Montelukast 4 Mg Oral Granule

Drug

Other names: Montelukast sodium

Placebos

Drug

Primary outcomes

  1. Length of hospital stay

    Time frame: within the 5 days from hospitalization

    The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.

Secondary outcomes

  1. Difference in clinical asthma score

    Time frame: Within 72 hours from hospitalization

    Improvement of clinical asthma scores between the 2 groups within 72 hours

Sponsors and collaborators

Lead sponsor

Kecioren Education and Training Hospital

Other

Registry information

Official study title

Phase 4 Study of Oral Montelukast Hospitalized Preschool Children

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2017
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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