Asthma, Behavior Problem, MontelukastNCT01818635
To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma
An observational study of Asthma, Behavior Problem, Montelukast, run by Fatih University at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma. Read more about this study
- Who is it for?
- Ages 18 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Behavior Problem, Montelukast
- How many people
- 600 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Mar 2013to Jan 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: We planned to include who who treated for asthmatic children and healthy controls in the study.
Who may be able to join
- 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
Who cannot join
- Children with other chronic disease
- Children with chronic drug use (except for the treatment of asthma)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fatih University Medical School
Ankara, 06510
Fatih University
Ankara, 06510
About this study
Official title: 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.
- Conditions
- Asthma, Behavior Problem, Montelukast
- Medical subject headings
- Asthma, Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (1)
To compare the effects of inhaled corticosteroids and montelukast on the behavior problems.
In this study, it will be compared the effect on behavior changes between intake of inhaled steroid and montelukast.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Behavior Problem, MontelukastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Fatih University
- Sponsor type
- University, hospital or other
- Collaborators
- Kecioren Teaching and Research Hospital
- Responsible party
- Principal investigator, Ahmet Z. Akelma, Fatih University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818635
- Sponsor's protocol ID
- FK-0663
- Status last verified
- Aug 2015
- First submitted
- 22 Mar 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of to Investigation the Effect of Montelukast on Behavior Problems in Children With Asthma
- ClinicalTrials.gov ID
- NCT01818635
- Acronym / sponsor ID
- FK-0663
- Conditions
- Asthma, Behavior Problem, Montelukast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fatih UniversityUniversity, hospital or other
- Collaborators
- Kecioren Teaching and Research Hospital
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We planned to include who who treated for asthmatic children and healthy controls in the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Children with other chronic disease
- Children with chronic drug use (except for the treatment of asthma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
To compare the effects of inhaled corticosteroids and montelukast on the behavior problems.
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, Behavior Problem, Montelukast, run by Fatih University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the effect of montelukast on behavior problems in children with asthma (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.