Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Acute Bronchiolitis
- Sponsor
- Samarkand State Medical Institute
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Group I (control group)
40 patients with obstructive bronchitis who received placebo
Intervention: Placebo
Group II
40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day
Intervention: Montelukast Sodium
Outcomes
Primary Outcomes
Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis
Time Frame: 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.