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Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children

NCT ID: NCT03369119

Last Updated: 2017-12-11

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations.

The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.

Detailed Description

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Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.

Objective: To evaluate the effect of the addition of a single dose of oral montelukast to standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel group trial. Setting: Pediatric service of Education and training Hospital Patients: Children with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical asthma score was recorded before administering study medication and thereafter, 4 hourly until discharge. Main outcome measure: The primary outcome was discharge rates.

Conditions

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Acute Asthma Acute Wheezy Bronchitis

Keywords

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Acute asthma Montelukast Hospitalized children Preschool children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Montelukast

Children received 4 mg oral montelukast granule daily until discharge.

Group Type ACTIVE_COMPARATOR

Montelukast 4 Mg Oral Granule

Intervention Type DRUG

Placebo

Children receive 4 mg oral placebo montelukast granule daily until discharge

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

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Montelukast 4 Mg Oral Granule

Intervention Type DRUG

Placebos

Intervention Type DRUG

Other Intervention Names

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Montelukast sodium

Eligibility Criteria

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Inclusion Criteria

* Medical history of at least 4 wheezing attacks
* Children with the ages of 6-60 months
* Children whose parents accept to give written informed consent

Exclusion Criteria

* Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)
* Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)
Minimum Eligible Age

6 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kecioren Education and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cem Hasan Razi

Pediatric Allergy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cem H. Razi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pediatric Allergy Specialist

Locations

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Kecioren Education and Training Hospital

Ankara, Keçiören, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.10.0.İEG.0.11.00.01/003247

Identifier Type: -

Identifier Source: org_study_id