Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children
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|ClinicalTrials.gov Identifier: NCT03369119|
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Asthma Acute Wheezy Bronchitis||Drug: Montelukast 4 Mg Oral Granule Drug: Placebos||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 4 Study of Oral Montelukast Hospitalized Preschool Children|
|Actual Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Montelukast
Children received 4 mg oral montelukast granule daily until discharge.
Drug: Montelukast 4 Mg Oral Granule
Other Name: Montelukast sodium
Placebo Comparator: Placebo
Children receive 4 mg oral placebo montelukast granule daily until discharge
- 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.
- Difference in clinical asthma score [ Time Frame: Within 72 hours from hospitalization ]Improvement of clinical asthma scores between the 2 groups within 72 hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369119
|Kecioren Education and Training Hospital|
|Ankara, Keçiören, Turkey, 06380|
|Principal Investigator:||Cem H. Razi, M.D.||Pediatric Allergy Specialist|