OP0201 as an Adjunct Treatment for Acute Otitis Media

Protocol Description

This study is looking at the safety and feasibility of treating young children with ear infections with a 10-day course of a medicine called OP0201.OP0201 is given in the nose using an inhaler type of device. The active ingredients are: dipalmitoylphosphatidylcholine and cholesteryl palmitate, both components of human surfactants which are well understood natural compounds that our bodies make in our nasal passages and lung tissues. Surfactants help fluids to flow. In children with ear infections, we know that the amount of surfactant is reduced compared to children without ear infections. Accordingly, we are studying OP0201 to see if it helps the body drain the fluid that builds up behind the ear drum in children with ear infections and potentially use less antibiotics.

Benefits

Children enrolled in the study will have careful monitoring and follow-up for their ear infection through resolution of the episode. There are no charges for visits or study medications. The study team is available by phone; 24 hours a day.

Eligibility Criteria

Subject to certain exclusion criteria; this study is open to children ages 6 to 24 months who have been diagnosed with an ear infection.

Requirements

This study has three visits (an enrollment visit and two follow-up visits). Participants enrolled in the study will receive antibiotics and either a 10-day course of OP0201 or placebo (fake medicine). At study visits, we will examine your child’s ears, take a picture of the ear drum and perform a tympanogram (a test to measure the movement of the eardrum with a small amount of air). We will also ask you to complete a daily diary of symptoms.

Status: Open to Enrollment

Source(s) of Support

Novus Therapeutics

Primary Investigator

Alejandro Hoberman, MD

Contact Information

For additional information or to enroll, please contact 412-692-7382.