Chronic Sinusitis

About Chronic Sinusitis Clinical Trials (Click to Open)

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Chronic Sinusitis

General Purpose:

At one time or another, we all experience the aggravation of a stuffy nose, drainage in the throat, and pain and swelling around the nose and eyes. These symptoms are usually attributed to the common cold and are thankfully only temporary; however, some individuals can suffer from these symptoms for months at a time, in which case they are dealing with a condition known as chronic sinusitis.

Individuals who have chronic sinusitis may also experience ear pain, pain in the upper jaw, cough, sore throat, fatigue, bad breath, and even nausea.

Chronic sinusitis frequently occurs as a result of nasal polyps (tissue growths that block the sinuses), allergies and allergic reactions, a crooked septum (the barrier between the two nostrils), and facial trauma. In addition, chronic sinusitis may also arise as a complication of cystic fibrosis, gastroesophageal reflux, and disorders of the immune system.

People who are at the greatest risk of developing chronic sinusitis are those with a nasal passage deformity, those with a sensitivity to aspirin, individuals with chronic lung disease, those with immune system disorders such as cystic fibrosis or HIV/AIDS, individuals with asthma, and those who are regularly exposed to pollutants in the air.

If left untreated, chronic sinusitis can have serious complications, including triggering asthma attacks, leading to meningitis (inflammation of the membranes that surround the brain and spinal cord), permanent eye damage, and increased risk of stroke.

A number of research studies are underway to better understand the role of the immune system in the development of chronic sinusitis, as well as to develop more effective methods of managing symptoms and preventing chronic sinusitis in at-risk individuals.

What Will Chronic Sinusitis Clinical Trials Be like?

When participating in a clinical trial designed to investigate some aspect related to chronic sinusitis, there are a few basic tests and procedures you may receive; however, the ultimate design of the particular study will determine which specific procedures you will undergo. The following is a list of some tests and procedures that may be used in clinical trials for chronic sinusitis:

  • Detailed physical examination (including a visual inspection of the nasal passages) and medical history.
  • Nasal endoscopy / rhinoscopy: a procedure during which a thin and flexible tube with a tiny light and camera attached to the end is inserted through the nose to allow doctors to better visualize the nasal passages.
  • Imaging procedures such as computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive, similar to x-rays, and provide detailed pictures of areas inside your body. They can be used by doctors to identify areas of inflammation or abnormalities within the sinuses.
  • Nasal cultures: a procedure during which a small sample of tissue is taken for microscopic evaluation. This can help determine what bacteria, fungi, or virus is causing the chronic sinusitis.
  • Allergy skin tests

Typical Chronic Sinusitis Clinical Trial Protocol:

Current research related to chronic sinusitis covers a broad range of topics. Specific examples might include the following:

  • A study to investigate the genetic factors associated with chronic sinusitis and to identify genes that are involved in its development and progression. In such a study, healthy volunteers without a history of chronic sinusitis, as well as individuals with a diagnosis of chronic sinusitis would donate blood samples to be studied.
  • A study to determine if vitamin D supplementation helps to improve the symptoms associated with chronic sinusitis. In this study, half of the patients would be randomly assigned to receive vitamin D while the other half would receive a placebo.
  • A randomized clinical trial to determine if patients who have both chronic sinusitis and depression report an improvement in their chronic sinusitis following treatment with the antidepressant medication escitalopram. This study would randomly assign patients to receive treatment with either the antidepressant or a placebo.
  • An observational study designed to develop and validate a new assessment tool for measuring facial pain and nasal discomfort in individuals with chronic sinusitis.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time, the investigational treatment might be compared to a placebo alone (such as in the second and third examples provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

Trial Eligibility and Medical Information Needed:

  • Duration of your sinusitis
  • Any identifiable triggers that make your symptoms worse
  • A list of your current medications (including prescription, non-prescription, vitamins, and dietary supplements)
  • A list of your previous treatments for sinusitis

Suggested Search Terms:

When searching for information related to clinical trials and chronic sinusitis, the following terms might be of use: “chronic sinusitis children,” “chronic sinusitis pediatric,” “chronic sinusitis treatment,” “chronic sinusitis surgery,” “chronic sinusitis allergies,” “chronic sinusitis cystic fibrosis,” “chronic sinusitis asthma,” “chronic sinusitis smoking,” and “chronic sinusitis asthma.”

Current Search Term:

“Chronic Sinusitis”

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Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis


Condition:   Maxillary Sinusitis
Interventions:   Procedure: treatment of chronic maxillary sinusitis using DIVA system;   Device: "dynamic implant valve approach" - DIVA system
Sponsor:   Western Galilee Hospital-Nahariya
Not yet recruiting - verified March 2017


Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS


Condition:   Chronic Sinus Infection
Intervention:   Device: Sinopsys® Lacrimal Stent
Sponsor:   Sinopsys Surgical
Recruiting - verified April 2017


Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure


Conditions:   Chronic Sinusitis;   Frontal Sinusitis
Intervention:   Device: Porcine Intestinal submucosal xenograft
Sponsor:   University of California, Los Angeles
Recruiting - verified November 2016


480 Biomedical Sinus Drug Depot


Condition:   Chronic Sinusitis
Intervention:   Drug: 480 Mometasone Furoate Sinus Drug Depot
Sponsor:   480 Biomedical, Inc.
Not yet recruiting - verified November 2016


In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps


Conditions:   Sinusitis;   Nasal Polyps
Interventions:   Procedure: Endoscopic polypectomy in clinic (EPIC);   Procedure: Endoscopic Sinus Surgery (ESS);   Other: General Anesthesia;   Other: Local and topical anesthesia
Sponsors:   Ottawa Hospital Research Institute;   Canadian Institutes of Health Research (CIHR);   Medtronic
Not yet recruiting - verified January 2017


A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation


Condition:   Chronic Sinusitis
Interventions:   Device: Propel Mini Sinus Implant;   Procedure: In-office Sinus Dilation
Sponsor:   Intersect ENT
Active, not recruiting - verified October 2016


Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications


Condition:   Chronic Sinusitis
Interventions:   Device: Composite Removable Sinus Stent;   Drug: adrenaline-lidocaine;   Procedure: cold saline wash
Sponsor:   STS Medical
Recruiting - verified April 2017


The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery


Condition:   Chronic Sinusitis
Interventions:   Device: Steroid-releasing sinus implant;   Other: Post-op standard of care
Sponsors:   ENT and Allergy Associates, LLP;   Intersect ENT
Completed - verified November 2016


The PIO II Study of In-office Placement of a Steroid-eluting Sinus Implant


Condition:   Chronic Sinusitis
Interventions:   Device: Steroid-releasing sinus implant;   Other: Post-op standard of care
Sponsors:   Collin County Ear Nose & Throat;   Intersect ENT
Completed - verified November 2016


Clinical Evaluation of Safety and Efficacy of S8 Sinus Implant in Chronic Sinusitis Patients


Conditions:   Chronic Sinusitis;   Nasal Polyposis
Interventions:   Drug: S8 Sinus Implant;   Drug: Steroid nasal spray
Sponsor:   Intersect ENT
Completed - verified March 2017


Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus


Condition:   Chronic Sinusitis
Interventions:   Device: PROPEL Mini or Nova Sinus Implant.;   Procedure: Sinus Surgery only.
Sponsor:   Intersect ENT
Active, not recruiting - verified June 2016


Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia


Condition:   Chronic Sinusitis With Nasal Polyps and Eosinophilia
Intervention:   Drug: dexpramipexole
Sponsor:   Knopp Biosciences
Completed - verified February 2017


Association of Periostin Levels and Chronic Sinusitis


Conditions:   Sinusitis;   Nasal Polyps
Intervention:   Other: Blood draw
Sponsor:   University of Virginia
Withdrawn - verified May 2017


Safety and Performance of the Steroid-Releasing S8 Sinus Implant


Condition:   Chronic Sinusitis
Intervention:   Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Sponsor:   Intersect ENT
Completed - verified March 2017


Safety and Efficacy of a Steroid-Releasing Sinus Implant for Recurrent Sinus Obstruction


Condition:   Chronic Sinusitis
Interventions:   Drug: S8 Sinus Implant;   Procedure: Sham procedure
Sponsor:   Intersect ENT
Completed - verified March 2017


Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery


Condition:   Chronic Sinusitis
Interventions:   Drug: Cocaine;   Drug: Adrenaline
Sponsor:   Marc Tewfik
Completed - verified March 2017


Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps


Condition:   Chronic Sinusitis With or Without Nasal Polyps
Intervention:   Drug: Fluticasone Propionate
Sponsor:   Optinose US Inc.
Completed - verified August 2016


12-Month OL Safety Study of Intranasal 400 μg of Fluticasone Propionate BID Using a Novel Bi-Directional Device in CS Patients


Condition:   Chronic Sinusitis: [Nos] or [Ethmoidal] or [Chronic Pansinusitis] or [Sphenoidal]
Intervention:   Drug: rescue med
Sponsor:   Optinose US Inc.
Completed - verified September 2016


The Clinical Efficacy of Topical Nasal Pomegranate Fruit Extract for Patients With Chronic Rhinosinusitis


Conditions:   Rhinitis;   Sinusitis;   Nasal Polyps
Intervention:  
Sponsors:   Hillel Yaffe Medical Center;   Gan Shmuel Food LTD. Kibbutz Gan Shmuel. POB HEFER 30010.
Recruiting - verified November 2016


Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up


Condition:   Chronic Sinusitis
Interventions:   Device: Balloon Sinus Dilation;   Procedure: Functional Endoscopic Sinus Surgery
Sponsor:   Entellus Medical, Inc.
Completed - verified January 2017


Vitamin D for Chronic Sinusitis


Condition:   Chronic Sinusitis
Interventions:   Dietary Supplement: vitamin D placebo;   Dietary Supplement: Vitamin D
Sponsor:   University of Chicago
Completed - verified August 2016


Clinical Study to Improve Diagnosis and Treatment of Sinusitis


Condition:   Chronic Sinusitis
Intervention:  
Sponsors:   Ohio State University;   National Institutes of Health (NIH);   National Center for Research Resources (NCRR)
Completed - verified April 2017


Xylitol Versus Saline in Chronic Sinusitis


Condition:   Chronic Sinusitis
Interventions:   Drug: Xylitol;   Drug: Saline
Sponsor:   University of Iowa
Completed - verified March 2017


Genetic Factors in Chronic Sinusitis


Condition:   Chronic Sinusitis
Intervention:  
Sponsor:   University of Chicago
Recruiting - verified August 2016


Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study


Conditions:   Chronic Sinusitis;   Rhinosinusitis;   Nasal Polyps
Intervention:   Drug: Prednisone
Sponsors:   Northwestern University;   National Heart, Lung, and Blood Institute (NHLBI)
Active, not recruiting - verified December 2016

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