Otitis Media With Effiusion Clinical Trial
Official title:
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
| Verified date | September 2015 |
| Source | Hormozgan University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Iran: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 143 |
| Est. completion date | April 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 6 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Hormozgan University of Medical Sciences | Bandar Abbas | Hormozgan |
| Lead Sponsor | Collaborator |
|---|---|
| Hormozgan University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment response | Defined as complete, partial, or no response based on the physician examination | 1 months | No |
| Secondary | Drug side effects | Frequency of Drug side effects as reported by the children or their parents | 1 month | Yes |