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

NCT ID: NCT04613180

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Acute Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (control group)

40 patients with obstructive bronchitis who received placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo containing no active substance

Group II

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

Group Type ACTIVE_COMPARATOR

Montelukast Sodium

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Placebo

placebo containing no active substance

Intervention Type DRUG

Other Intervention Names

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Singulair

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samarkand State Medical Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samarkand State Medical Institute

Samarkand, , Uzbekistan

Site Status

Countries

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Uzbekistan

Other Identifiers

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DGU 20170692

Identifier Type: -

Identifier Source: org_study_id