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

Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04613180
Enrollment
100
Registered
2020-11-03
Start date
2018-01-03
Completion date
2024-06-01
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchiolitis

Keywords

Montelukast sodium, Prevention, Relapse, Obstructive bronchitis

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.

Interventions

DRUGMontelukast Sodium

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.

DRUGPlacebo

placebo containing no active substance

Sponsors

Samarkand State Medical Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitisup to 24 monthsChildren 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.

Countries

Uzbekistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026