Clincosm LogoSign in Get a demo

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

Sponsor
Samarkand State Medical Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04613180
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
76.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Montelukast Sodium
  • Drug: Placebo
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
Actual Study Start Date :
Jan 3, 2018
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group I (control group)

40 patients with obstructive bronchitis who received placebo

Drug: Placebo
placebo containing no active substance
Active Comparator: Group II

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

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.
Other Names:
  • Singulair

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis [up to 24 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 7 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samarkand State Medical Institute Samarkand Uzbekistan 140100

    Sponsors and Collaborators

    • Samarkand State Medical Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Samarkand State Medical Institute
    ClinicalTrials.gov Identifier:
    NCT04613180
    Other Study ID Numbers:
    • DGU 20170692
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Nov 3, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Samarkand State Medical Institute
    Montelukast sodium
    Prevention
    Relapse
    Obstructive bronchitis
    Additional relevant MeSH terms:
    Bronchiolitis
    Bronchitis
    Montelukast

    Study Results

    No Results Posted as of Nov 3, 2020