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NCT02541760

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

Completed Phase 3 Last updated 2 September 2015
What this trial tests

Phase 3 trial testing Monteleukast in Otitis Media With Effiusion in 143 participants. Completed in 1 April 2015.

Timeline
1 April 2014
Primary endpoint
1 March 2015
1 April 2015

Quick facts

Lead sponsorHormozgan University of Medical Sciences
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment143
Start date1 April 2014
Primary completion1 March 2015
Estimated completion1 April 2015
Sites1 location across Iran

Drugs / interventions tested

Conditions studied

Sponsor

Hormozgan University of Medical Sciences

Who can join

Adults 2 to 6, any sex, with Otitis Media With Effiusion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial.
    Rahmati MB, Safdarian F, Shiroui B, Zare S, et al · · 2017 · cited 2× · PMID 28894551 · DOI 10.19082/4890

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Trials by the same sponsor.

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