Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
NCT ID: NCT02541760
Last Updated: 2015-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
143 participants
INTERVENTIONAL
2014-04-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Montelukast
4 ml monteleukast daily for one month
Monteleukast
4 ml monteleukast daily for one month
Mometasone
Inhaled mometasone 1 puff in each side of nose for one month
Mometasone
Inhaled mometasone 1 puff in each side of nose for one month
Control
No intervention
No interventions assigned to this group
Interventions
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Monteleukast
4 ml monteleukast daily for one month
Mometasone
Inhaled mometasone 1 puff in each side of nose for one month
Eligibility Criteria
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Inclusion Criteria
* Definite diagnosis of OME with symptoms and examination
Exclusion Criteria
* Chronic pulmonary or cardiac diseases or immune deficiency
* Allergic rhinitis
* Hypersensitivity to monteleukast or corticosteroids
* Avoidance of parents to fill the written informed consent
2 Years
6 Years
ALL
No
Sponsors
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Hormozgan University of Medical Sciences
OTHER
Responsible Party
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Hamidreza Mahboobi
Principal Investigator
Principal Investigators
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Hamidreza Mahboobi, M.D
Role: PRINCIPAL_INVESTIGATOR
Hormozgan University of Medical Sciences
Locations
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Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, Iran
Countries
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References
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Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Tudor-Green B, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Dec 13;12(12):CD015255. doi: 10.1002/14651858.CD015255.pub2.
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.
Other Identifiers
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163
Identifier Type: -
Identifier Source: org_study_id
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