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

September 2, 2015 updated by: Hamidreza Mahboobi, Hormozgan University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Hormozgan
      • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
        • Hormozgan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Montelukast
4 ml monteleukast daily for one month
Drug: Monteleukast
4 ml monteleukast daily for one month
Active Comparator: Mometasone
Inhaled mometasone 1 puff in each side of nose for one month
Drug: Mometasone
Inhaled mometasone 1 puff in each side of nose for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response
Time Frame: 1 months
Defined as complete, partial, or no response based on the physician examination
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug side effects
Time Frame: 1 month
Frequency of Drug side effects as reported by the children or their parents
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hormozgan University of Medical Sciences

Investigators

  • Principal Investigator: Hamidreza Mahboobi, M.D, Hormozgan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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