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Completed

NCT Number: NCT01304901

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

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.

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kecioren Education and Training Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

montelukast 4 mg granule

Drug

Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.

Montelukast placebo granüle

Drug

Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Other names: Montelukast placebo granule

Primary outcomes

  1. Difference of pulmonary index score from baseline to 120 minutes.

    Time frame: 0 to 120 minutes

    İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.

Secondary outcomes

  1. Proportion of discharge from emergency department.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kecioren Education and Training Hospital

Other

Registry information

Official study title

Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 28, 2011
Registry last updated
Dec 20, 2011

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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