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

Phase 3

Completed

• Conditions: Otitis Media With Effiusion
• Interventions: Drug: Monteleukast; Drug: Mometasone

• Registration Number: NCT02541760
• Lead Sponsor: Hormozgan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-02
• Last Update Submitted: 2015-09-02
• Study First Posted: 2015-09-04
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• • Children who were between 2 to 6 years old

  • Definite diagnosis of OME with symptoms and examination

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Montelukast	Monteleukast	4 ml monteleukast daily for one month
Mometasone	Mometasone	Inhaled mometasone 1 puff in each side of nose for one month

Primary Outcome Measures

Name	Time	Method
Treatment response	1 months	Defined as complete, partial, or no response based on the physician examination

Secondary Outcome Measures

Name	Time	Method
Drug side effects	1 month	Frequency of Drug side effects as reported by the children or their parents

Trial Locations

Locations (1)

Hormozgan University of Medical Sciences; 🇮🇷 Bandar Abbas, Hormozgan, Iran, Islamic Republic of