A Phase 4 interventional study of Montelukast 4 Mg Oral Granule and Placebos in Acute Asthma and Acute Wheezy Bronchitis, sponsored by Kecioren Education and Training Hospital. Completed at 1 site in Turkey. Open to participants aged 6 Months to 60 Months. Per ClinicalTrials.gov, last updated 2017-12-11.
Sponsored by Kecioren Education and Training Hospital · Phase 4, Interventional, and Treatment
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 100 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Kecioren Education and Training Hospital is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children received 4 mg oral montelukast granule daily until discharge.
Drug: Montelukast 4 Mg Oral Granule
Children receive 4 mg oral placebo montelukast granule daily until discharge
Drug: Placebos
Also known as: Montelukast sodium
Length of hospital stay
The primary outcome was the difference in mean length of hospital stay as an hour between the 2 groups.
Time frame: within the 5 days from hospitalization
Difference in clinical asthma score
Improvement of clinical asthma scores between the 2 groups within 72 hours
Time frame: Within 72 hours from hospitalization
Ran from Aug 2011 to primary completion in Oct 2012, 14 months.
Of 90 non-industry phase 4 interventional studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 14 months is below that.
Counting every sponsor, half of 156 studies reached it within 24 months; a quarter within 11 and three quarters within 37.
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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Montelukast
Kecioren Education and Training Hospital