Back to resultsEvaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
Primary Purpose
Acute Bronchiolitis
Status
Active
Phase
Phase 4
Locations
Uzbekistan
Study Type
Interventional
Intervention
Montelukast Sodium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bronchiolitis focused on measuring Montelukast sodium, Prevention, Relapse, Obstructive bronchitis
Eligibility Criteria
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
Sites / Locations
- Samarkand State Medical Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group I (control group)
Group II
Arm Description
40 patients with obstructive bronchitis who received placebo
40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04613180
First Posted
October 7, 2020
Last Updated
October 27, 2020
Sponsor
Samarkand State Medical Institute
1. Study Identification
Unique Protocol Identification Number
NCT04613180
Brief Title
Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
Official Title
Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samarkand State Medical Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchiolitis
Keywords
Montelukast sodium, Prevention, Relapse, Obstructive bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I (control group)
Arm Type
Placebo Comparator
Arm Description
40 patients with obstructive bronchitis who received placebo
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
40 patients who received oral montelukast sodium oral, at a dosage of 0.2-0.4 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Montelukast Sodium
Other Intervention Name(s)
Singulair
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo containing no active substance
Primary Outcome Measure Information:
Title
Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis
Description
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.
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samarkand State Medical Institute
City
Samarkand
ZIP/Postal Code
140100
Country
Uzbekistan
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://academic.oup.com/pch
Description
Journal of Paediatrics & Child Health
Learn more about this trial
Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
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