Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
1 other identifier
interventional
143
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2014
Shorter than P25 for phase_3
1 active site
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
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedSeptember 4, 2015
September 1, 2015
11 months
September 2, 2015
September 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment response
Defined as complete, partial, or no response based on the physician examination
1 months
Secondary Outcomes (1)
Drug side effects
1 month
Study Arms (3)
Montelukast
EXPERIMENTAL4 ml monteleukast daily for one month
Mometasone
ACTIVE COMPARATORInhaled mometasone 1 puff in each side of nose for one month
Control
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- Children who were between 2 to 6 years old
- Definite diagnosis of OME with symptoms and examination
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, 097145-3388, Iran
Related Publications (2)
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.
PMID: 38088821DERIVEDRahmati 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.
PMID: 28894551DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hamidreza Mahboobi, M.D
Hormozgan University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 4, 2015
Study Start
April 1, 2014
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
September 4, 2015
Record last verified: 2015-09