Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Primary Purpose
Otitis Media With Effiusion
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Monteleukast
Mometasone
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effiusion
Eligibility Criteria
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
Sites / Locations
- Hormozgan University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Montelukast
Mometasone
Control
Arm Description
4 ml monteleukast daily for one month
Inhaled mometasone 1 puff in each side of nose for one month
No intervention
Outcomes
Primary Outcome Measures
Treatment response
Defined as complete, partial, or no response based on the physician examination
Secondary Outcome Measures
Drug side effects
Frequency of Drug side effects as reported by the children or their parents
Full Information
NCT ID
NCT02541760
First Posted
September 2, 2015
Last Updated
September 2, 2015
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02541760
Brief Title
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Official Title
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effiusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montelukast
Arm Type
Experimental
Arm Description
4 ml monteleukast daily for one month
Arm Title
Mometasone
Arm Type
Active Comparator
Arm Description
Inhaled mometasone 1 puff in each side of nose for one month
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Monteleukast
Intervention Description
4 ml monteleukast daily for one month
Intervention Type
Drug
Intervention Name(s)
Mometasone
Intervention Description
Inhaled mometasone 1 puff in each side of nose for one month
Primary Outcome Measure Information:
Title
Treatment response
Description
Defined as complete, partial, or no response based on the physician examination
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Drug side effects
Description
Frequency of Drug side effects as reported by the children or their parents
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamidreza Mahboobi, M.D
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
097145-3388
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28894551
Citation
Rahmati MB, Safdarian F, Shiroui B, Zare S, Sadeghi N. Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial. Electron Physician. 2017 Jul 25;9(7):4890-4894. doi: 10.19082/4890. eCollection 2017 Jul.
Results Reference
derived
Learn more about this trial
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
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