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Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.

NCT ID: NCT01304901

Last Updated: 2011-12-20

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.

Detailed Description

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Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.

The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.

Conditions

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Asthma Acute Asthma

Keywords

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Acute asthma Children Montelukast Emergency room

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1-Montelukast

Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.

Group Type ACTIVE_COMPARATOR

montelukast 4 mg granule

Intervention Type DRUG

Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.

2- Placebo

Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Group Type PLACEBO_COMPARATOR

Montelukast placebo granüle

Intervention Type DRUG

Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Interventions

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montelukast 4 mg granule

Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.

Intervention Type DRUG

Montelukast placebo granüle

Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.

Intervention Type DRUG

Other Intervention Names

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Montelukast placebo granule

Eligibility Criteria

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Inclusion Criteria

* 6 months to 6 years of age
* With at least three episodes of wheezing in the previous 12 months
* Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score \[PIS\] of 7 to 13

Exclusion Criteria

* Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
* Who had any change in their dose of ICSs in the past 2 months
* Who had taken systemic corticosteroid within 1 months
* Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

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

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CEM H RAZİ, M.D.

Role: STUDY_DIRECTOR

Kecioren Education and Training Hospital

ELİF YAĞLI ÇOLAKOĞLU, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kecioren Education and Training Hospital

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-0.15-00-01/5181

Identifier Type: -

Identifier Source: org_study_id