- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541760
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
September 2, 2015 updated by: Hamidreza Mahboobi, Hormozgan University of Medical Sciences
Otitis media is one of the most common infections among children and is a complication in about 30% of common colds.
The most common complication of acute otitis media is otitis media with effusion.
Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion.
However, current information is inadequate in this issue.
The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Phase 3
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
-
-
Hormozgan
-
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
- Hormozgan University of Medical Sciences
-
-
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
5 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Children who were between 2 to 6 years old
- Definite diagnosis of OME with symptoms and examination
Exclusion Criteria:
• Currently were using corticosteroids or prophylactic monteleukast
- Chronic pulmonary or cardiac diseases or immune deficiency
- Allergic rhinitis
- Hypersensitivity to monteleukast or corticosteroids
- Avoidance of parents to fill the written informed consent
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention
|
|
Experimental: Montelukast
4 ml monteleukast daily for one month
|
4 ml monteleukast daily for one month
|
Active Comparator: Mometasone
Inhaled mometasone 1 puff in each side of nose for one month
|
Inhaled mometasone 1 puff in each side of nose for one month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment response
Time Frame: 1 months
|
Defined as complete, partial, or no response based on the physician examination
|
1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug side effects
Time Frame: 1 month
|
Frequency of Drug side effects as reported by the children or their parents
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hamidreza Mahboobi, M.D, Hormozgan University of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
September 2, 2015
First Submitted That Met QC Criteria
September 2, 2015
First Posted (Estimate)
September 4, 2015
Study Record Updates
Last Update Posted (Estimate)
September 4, 2015
Last Update Submitted That Met QC Criteria
September 2, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 163
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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-
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-
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