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

Primary Purpose

Otitis Media With Effiusion

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Monteleukast
Mometasone
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media With Effiusion

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hormozgan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Montelukast

Mometasone

Control

Arm Description

4 ml monteleukast daily for one month

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

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2015
Last Updated
September 2, 2015
Sponsor
Hormozgan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02541760
Brief Title
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Official Title
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effiusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montelukast
Arm Type
Experimental
Arm Description
4 ml monteleukast daily for one month
Arm Title
Mometasone
Arm Type
Active Comparator
Arm Description
Inhaled mometasone 1 puff in each side of nose for one month
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Monteleukast
Intervention Description
4 ml monteleukast daily for one month
Intervention Type
Drug
Intervention Name(s)
Mometasone
Intervention Description
Inhaled mometasone 1 puff in each side of nose for one month
Primary Outcome Measure Information:
Title
Treatment response
Description
Defined as complete, partial, or no response based on the physician examination
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Drug side effects
Description
Frequency of Drug side effects as reported by the children or their parents
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamidreza Mahboobi, M.D
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
097145-3388
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28894551
Citation
Rahmati 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.
Results Reference
derived

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

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