Clinical Trial 41941

Los Angeles, CA 90025


Summary:

SUFFERING FROM CHRONIC SINUSITIS?

We are conducting this research study to evaluate the effectiveness and safety of an investigational treatment for adults with chronic sinusitis.

The investigational treatment is a liquid spray medication dispensed by a new type of delivery system that is designed to place the medication high and deep into the sinuses. The medicine is delivered through the nose using pressure created by the user blowing into the delivery system.

This research study involves 6 visits to the study center over a period of about 26 weeks. The study staff will also call study participants twice between the 5th and 6th clinic visits.

Eligible study participants will be randomly assigned a treatment and will receive either the study treatment with active medication or placebo (a substance that looks like the study medication but has no active ingredients). Out of every 3 participants, 2 will receive the study treatment with active medication and 1 will receive placebo. Neither the study participants nor the study doctor will know which participants receive placebo.



WHO CAN PARTICIPATE IN THIS RESEARCH STUDY?

To qualify for this study, potential study participants must be age 18 or older and must have had (for a minimum of 12 weeks) at least 2 of these symptoms:

• Congestion

• Nasal discharge

• Facial pain and pressure, in the “sinus” region

• Loss or reduction in the sense of smell

The complete list of requirements will be explained by the staff at the study clinic.


Qualified Participants May Receive:

All medical examinations, study visits, and the study treatment required by the study are provided to qualified participants at no cost. Compensation will also be available for time and travel expenses incurred in study participation.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.