Trial | NCT04613180  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    100
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.
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 Started
Jan 03
2018
Primary Completion
Dec 30
2023
Anticipated
Study Completion
Jun 01
2024
Anticipated
Last Update
Nov 03
2020

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

Drug Placebo

placebo containing no active substance

Group II Active Comparator

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

Group I (control group) Placebo Comparator

40 patients with obstructive bronchitis who received placebo

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
No Results Posted