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NCT04613180 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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