To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma

August 12, 2015 updated by: Ahmet Z. Akelma, Fatih University

Phase 4 Study of to Investigation the Effect of Montelukast on Behavior Problems in Children With Asthma

The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

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

  • Turkey
      • Ankara, Turkey, 06510
        • Fatih University Medical School
      • Ankara, Turkey, 06510
        • Fatih University

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

1 year to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We planned to include who who treated for asthmatic children and healthy controls in the study.

Description

Inclusion Criteria:

  • To have asthmatic children aged 18-60 months
  • To have that receive prophylactic treatment for asthma
  • Healthy children will be enrolled among those being brought for routine controls

Exclusion Criteria:

  • Children with other chronic disease
  • Children with chronic drug use (except for the treatment of asthma)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the effect of montelukast on behavior problems in children with asthma
Time Frame: 8 months
Montelukast frequently used in the treatment of asthmatic children. However, we believe that montelukast lead to behavior problems. In this study, we aimed to investigate that intake of montelukast whether lead to behavior problems.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the effects of inhaled corticosteroids and montelukast on the behavior problems.
Time Frame: 8 months
In this study, it will be compared the effect on behavior changes between intake of inhaled steroid and montelukast.
8 months

Collaborators and Investigators

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

Sponsor

Fatih University

Collaborators

Kecioren Teaching and Research Hospital

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

March 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 25, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK-0663

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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