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

Acute Bronchiolitis Clinical Trial

Official title:

Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04613180
• Other study ID #: DGU 20170692
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 3, 2018
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2020
• Source: Samarkand State Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis
• Bronchitis

Intervention

Drug:
• Montelukast 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.
• Placebo
placebo containing no active substance

Locations

Country	Name	City	State
Uzbekistan	Samarkand State Medical Institute	Samarkand

Sponsors (1)

Lead Sponsor	Collaborator
Samarkand State Medical Institute

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Journal of Paediatrics & Child Health