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Trial record 65 of 433 for:    OTITIS

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

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ClinicalTrials.gov Identifier: NCT02541760
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hamidreza Mahboobi, 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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effiusion Drug: Monteleukast Drug: Mometasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
Drug Information available for: Mometasone

Arm Intervention/treatment
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

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. Treatment response [ Time Frame: 1 months ]
    Defined as complete, partial, or no response based on the physician examination


Secondary Outcome Measures :
  1. Drug side effects [ Time Frame: 1 month ]
    Frequency of Drug side effects as reported by the children or their parents



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541760


Locations
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Iran, Islamic Republic of
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
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Principal Investigator: Hamidreza Mahboobi, M.D Hormozgan University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamidreza Mahboobi, Principal Investigator, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02541760     History of Changes
Other Study ID Numbers: 163
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents