Nasal polyps are benign growths that arise in the nasal sinuses or nasal cavity. They can partially or completely obstruct the nasal passages, and cause symptoms such as a runny nose, persistent stuffiness, post-nasal drip, decreased or absent sense of smell, and facial pain.
Currently, this investigational product is approved for adults with nasal polyps, however there is no approved treatment for nasal polyps in people under the age of 18. Therefore, finding new treatments that may work for people with nasal polyps under the age of 18 could provide important options for those needing treatment.
The purpose of this research study is to evaluate the effectiveness and safety of an investigational medication for people ages 12 to 17 who have nasal polyps.
What is this research study?
We are conducting this medical research study to evaluate the effectiveness and safety of an investigational treatment for people age 12 to 17 who have nasal polyps.
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, where polyps form. The medication is delivered through the nose using pressure created by the user blowing into the delivery system.
This research study involves 7 visits to the study center over a period of about 30 weeks. The study staff will also call participants twice between the 6th and 7th clinic visits.
Eligible participants will be assigned to receive either the study treatment with active medication or placebo for the first 16 weeks of the treatment portion of the study. A
placebo is a substance that looks like the study medication but has no active ingredients. For weeks 17 through 28 of the treatment portion of the study, all participants will receive the study treatment with active study medication.
The treatment assignment for the first 16 weeks will be made randomly by a computer. Out of every 3 participants, 2 will receive the study 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 12 to 17 years of age at time of screening
- Have nasal polyps in both nasal cavities
The complete list of requirements will be discussed with you by the staff at the study clinic.
Does it cost anything to participate?
All medical examinations, study visits, and the study treatment are provided to qualified participants at no cost. Compensation will also be available for time and travel expenses incurred in study participation.
Are there any risks to participating in this research study?
There may be potential risks to participating in this research study. All drugs and medical procedures carry a risk of side effects; therefore, it is possible that participants may experience some discomfort or other side effects associated with the use of the study treatment. Before participants are asked to decide whether they wish to participate, the potential risks ofparticipation will be explained in detail.
What are the potential benefits of participating?
Participants may or may not receive any personal benefit from participating in this study. This study, however, may help to find new options to treat nasal polyps in people under the age of 18. New information that is received from this study may help to answer questions that doctors and medical researchers have about treatments for nasal polyps.
What should I do now?
If participating in this research study is something you think you and your child might be interested in, please talk with your family and then to your doctor. If you wish to take the next step toward possible participation, or have more questions, please fill out the form on this page and we will contact you shortly. Contacting us does not obligate you to participate in this research study.