Completed Studies

Allakos – Drug trial

AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis. in combination with an intranasal steroid versus intranasal steroid alone in the reduction of nasal polyp size.

RESOLVE II – Steroid-Releasing S8 Sinus Implant

This is the follow up study to the RESOLVE I- S8 Steroid- Releasing Implant Trial. The goal of this study was to assess the safety and efficacy of the steroid-releasing S8 Sinus Implant in individuals who have previously had functional endoscopic sinus surgery in the past but still experienced nasal and sinus obstruction. The S8 Sinus Implant creates and maintains an opening in the sinus and is intended to provide a physical opening in order to restore ventilation and drainage as well as decrease the feeling of nasal obstruction or congestion. Enrolled subjects who met eligibility criteria were randomly assigned (like flipping a coin) to one of two groups: a treatment group who received the implant and a control group who did not receive the implant. This study was sponsored by Intersect ENT.

Short-Term Steroid Therapy in Patients with Chronic Sinusitis (CRS) Without Nasal Polyps

In this study, we were interested in examining the most effective route to administer steroids to patients with chronic sinusitis (CRS). There is no conclusive data as to whether oral or sprayed nasal steroids are more effective in providing long-term benefit to patients. We compared patients compared patients treated with antibiotics and oral steroids to patients who receive antibiotics and nasally sprayed steroid therapy.

Improving Symptom-Based Diagnosis of Chronic Sinusitis (CRS)

This study’s aim was to better diagnose chronic sinusitis (CRS) by using a patient’s symptoms. We studied patterns of symptoms that will help us improve our ability to determine whether a patient has CRS or another condition with similar symptoms such as nasal allergies or migraine headaches. Eligible patients who presented for an initial evaluation of chronic nasal and sinus symptoms that could have suggested a sinusitis diagnosis answered a 15-minute questionnaire before seeing their ear, nose, and throat (ENT) physician. After seeing and examining the patient during their clinic visit, the ENT physician determined whether a sinus CT scan was necessary as part of standard medical care. If a CT scan would not have been performed as part of standard medical care, we obtained a low-dose CT scan (at no cost) for research purposes in order to confirm the diagnosis.

Patient Knowledge and Perception of Sinus CT Scans

In this study, new patients who were referred for, or believed they had a condition related to their nose or sinuses completed a 5 minute survey prior to seeing the examining physician. We studied patients’ knowledge and perceptions of in-office CT scans as well as their acceptance of CT scans as a necessary part of standard clinical care. We wanted to determine whether patients believed that a CT scan allows physicians to make more a definitive diagnosis and whether patients are willing to forego a CT scan even if the resulting diagnosis is potentially less accurate. We also wanted to assess the factors that influence patients’ knowledge of CT scans. Additionally, we studied the most common concerns that patients have relating to using a CT scan to help diagnose their nasal or sinus condition.

RESOLVE I – Steroid-Releasing S8 Sinus Implant Clinical Trial

The goal of this study was to assess the safety and efficacy of the steroid-releasing S8 Sinus Implant in individuals who had functional endoscopic sinus surgery in the past but still experienced nasal and sinus obstruction. The S8 Sinus Implant creates and maintains an opening in the sinus and is intended to provide a physical opening in order to restore ventilation and drainage as well as decrease the feeling of nasal obstruction or congestion. Enrolled subjects who met eligibility criteria were randomly assigned (like flipping a coin) to one of two groups: a treatment group who received the implant and a control group who did not receive the implant.

Steroid Therapy Before Surgery in Patients with Chronic Sinusitis (CRS) With Nasal Polyps

In this study, we studied which chronic sinusitis (CRS) patients benefit from steroids before they have surgery. For some doctors, it is common practice to use these medications immediately prior to planned sinus surgery, to lessen inflammation and possibly to help the healing process. Other physicians feel oral steroids may not be helpful in this way and there is no conclusive data as to whether this practice has long term benefit. Enrolled subjects had a diagnosis of CRS with nasal polyps and were scheduled for sinus surgery. Subjects were randomly assigned (like flipping a coin) to either receive oral steroids before their surgery or not to receive steroids before their surgery.

Laryngopharyngeal Reflux (LPR) pH Probe

In this study, we examined whether a device called a pH probe can help physicians predict if a patient will benefit from the current treatment for LPR, called proton pump inhibitor (PPI) medication. The Restech pH probe was worn by participants in  for 24 hours and measured acidity levels before eating, sleeping, and laying down, to assess reflux measures as a baseline prior to starting PPI medication.

OptiNose

In this study, were interested in determining whether a new device that administers steroid medications in the nose would help improve symptoms of nasal congestion and obstruction in patients with bilateral nasal polyps. Eligible patients who had nasal polyposis seen used the device to deliver steroids in your nose for about 6 months.

MERLOT – Medical Therapy Versus Balloon Sinus Dilation for Patients with Chronic Rhinosinusitis

In this study sponsored by Acclarent,we compared health outcomes for patients with chronic rhinosinusitis (CRS) who are treated with continued medical therapy and those who are treated with balloon sinus dilation, a surgical procedure. Both of these options are considered routine medical care.