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

Samarkand State Medical Institute

Status and phase: Active, not recruiting; Phase 4

Conditions: Acute Bronchiolitis

Treatments: Drug: Placebo; Drug: Montelukast Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT04613180

DGU 20170692

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Group I (control group)

Placebo Comparator group

Description:

40 patients with obstructive bronchitis who received placebo

Treatment:

Drug: Placebo

Group II

Active Comparator group

Description:

40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day

Treatment:

Drug: Montelukast Sodium