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

NCT04613180 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: DGU 20170692
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchiolitis

Keywords

Montelukast sodium; Prevention; Relapse; Obstructive bronchitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I (control group)

PLACEBO COMPARATOR

40 patients with obstructive bronchitis who received placebo

Drug: Placebo

Group II

ACTIVE COMPARATOR

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

Drug: Montelukast Sodium

Interventions

Montelukast Sodium DRUG

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.

Also known as: Singulair

Group II

Placebo DRUG

placebo containing no active substance

Group I (control group)

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• RDA score=6 points
• E:I index score \>1.40
• ineffective treatment at home for ≥48 hours
• adverse comorbidities

You may not qualify if:

• chronic or congenital diseases of the Central nervous, cardiovascular and bronchopulmonary systems

Sponsors & Collaborators

• Samarkand State Medical Institute: lead

Study Sites (1)

Samarkand State Medical Institute

Samarkand, 140100, Uzbekistan

Location

MeSH Terms

Conditions

Recurrence

Interventions

montelukast

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: November 3, 2020
• Study Start: January 3, 2018
• Primary Completion: December 30, 2023
• Study Completion: June 1, 2024
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)