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

Phase 4

• Conditions: Acute Bronchiolitis
• Interventions: Drug: Placebo; Drug: Montelukast Sodium

• Registration Number: NCT04613180
• Lead Sponsor: Samarkand State Medical Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-03
• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (control group)	Placebo	40 patients with obstructive bronchitis who received placebo
Group II	Montelukast Sodium	40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis	up to 24 months	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.

Trial Locations

Locations (1)

Samarkand State Medical Institute; 🇺🇿 Samarkand, Uzbekistan