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Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children

Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02541760
Enrollment
143
Registered
2015-09-04
Start date
2014-04-30
Completion date
2015-04-30
Last updated
2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media With Effiusion

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.

Interventions

DRUGMonteleukast

4 ml monteleukast daily for one month

Inhaled mometasone 1 puff in each side of nose for one month

Sponsors

Hormozgan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment response1 monthsDefined as complete, partial, or no response based on the physician examination

Secondary

MeasureTime frameDescription
Drug side effects1 monthFrequency of Drug side effects as reported by the children or their parents

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026