Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

June 13, 2011 updated by: Hormozgan University of Medical Sciences

Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Hormozgan
      • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79145-3388
        • Hormozgan University of Medical Sciences (HUMS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group
Experimental: Montelukast
4mg Montelukast daily for 2 months
Drug: Montelukast
Montelukast 4mg daily for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Distress Severity Score (RDSS)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average number of cough daily= as expressed parents during visits
Time Frame: 6 months
none= No cough, Mild=less than 10 daily, Severe=More than 10 daily
6 months
Wheezing severity in the physical examination by physician
Time Frame: 6 Months
None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hormozgan University of Medical Sciences

Investigators

  • Principal Investigator: Ali Asghar Parhiz, Resident, Hormzgan University of Medical Sciences (HUMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Montelukast for bronchiolitis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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