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OpenTrials
Completed

NCT Number: NCT02541760

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

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.

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Key information

Conditions

Otitis Media With Effiusion

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 097145-3388, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monteleukast

Drug

4 ml monteleukast daily for one month

Mometasone

Drug

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

Primary outcomes

  1. Treatment response

    Time frame: 1 months

    Defined as complete, partial, or no response based on the physician examination

Secondary outcomes

  1. Drug side effects

    Time frame: 1 month

    Frequency of Drug side effects as reported by the children or their parents

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.