Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis

Study Overview
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Brief Summary
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The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups.

Detailed Description
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The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups. Group I (control) included 40 patients who received standard therapy and placebo. Group II (main) included 40 patients who received standart therapy and oral montelukast sodium.

Official Title
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Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis

Conditions
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Acute Bronchiolitis

Intervention / Treatment
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* Drug: Montelukast Sodium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RDA score=6 points E:I index score >1.40 ineffective treatment at home for ≥48 hours adverse comorbidities Exclusion Criteria: chronic or congenital diseases of the Central nervous, cardiovascular and bronchopulmonary systems

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomly divided into 2 groups. I the group (control) included 40 patients who received standard therapy. The second group included 40 patients who received oral montelukast sodium. The therapeutic dosage of the drug was 0.2 mg/kg/day, the daily dose was prescribed once a day for the entire duration of the disease. As a prevention of repeated episodes of bronchial obstructive syndrome, the drug was prescribed at a dose of 0.1 mg/kg/day, the duration of anti-relapse therapy was 30 days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I (control group)<br>40 patients with obstructive bronchitis who received placebo | Drug: Placebo<br>* placebo containing no active substance<br>|
| Active Comparator: Group II<br>40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day | Drug: Montelukast Sodium<br>* Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older.<br>* Other names: Singulair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis | Children aged 1 to 7 years with recurrent obstructive bronchitis who will be treated in the Emergency Pediatrics and pediatric intensive care departments of the Emergency hospital of Samarkand will be examined. Patients will be randomly divided into 2 groups. Group I (control) will include 40 patients who received standard therapy and placebo. Group II will include 40 patients who received oral montelukast sodium in addition to standard therapy. Modified bronchophonography will be used to determine the effectiveness of the therapy. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Montelukast sodium, Prevention, Relapse, Obstructive bronchitis