Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

NCT ID: NCT01370187

Last Updated: 2011-06-14

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

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.

Detailed Description

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All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.

Conditions

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Bronchiolitis Wheezing Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Montelukast

4mg Montelukast daily for 2 months

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

Montelukast 4mg daily for 2 months

Interventions

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Montelukast

Montelukast 4mg daily for 2 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* infant in 3-12 months of age with first episode of wheezing or bronchiolitis
* written informed consent by parents

Exclusion Criteria

* Previous wheezing episode or confirmed asthma or bronchiolitis
* recent bronchodilator use
* immune deficient
* immunosuppressive drug use
* croup or pneumonia diagnosis
* loss of follow up
Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hormozgan University of Medical Sciences (HUMS)

Principal Investigators

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Ali Asghar Parhiz, Resident

Role: PRINCIPAL_INVESTIGATOR

Hormzgan University of Medical Sciences (HUMS)

Locations

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Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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Montelukast for bronchiolitis

Identifier Type: -

Identifier Source: org_study_id

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