NCT01818635

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

March 22, 2013

Last Update Submit

August 12, 2015

Conditions

Asthma, Behavior Problem, Montelukast

Outcome Measures

Primary Outcomes (1)

  • To investigate the effect of montelukast on behavior problems in children with asthma

    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 Outcomes (1)

  • To compare the effects of inhaled corticosteroids and montelukast on the behavior problems.

    8 months

Eligibility Criteria

Age18 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fatih University Medical School

Ankara, 06510, Turkey (Türkiye)

Location

Fatih University

Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaMental Disorders

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fatih University Medical School

Study Record Dates

First Submitted

March 22, 2013

First Posted

March 26, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

TU(2)