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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A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

Condition:   Nasal Polyps, Chronic Sinusitis
Interventions:   Drug: Omalizumab;   Drug: Placebo
Sponsor:   Hoffmann-La Roche

Xylitol for Chronic Sinusitis

Condition:   Chronic Rhinosinusitis
Interventions:   Drug: Xylitol;   Drug: Saline
Sponsor:   Ochsner Health System
Not yet recruiting

Radiologic Scoring of Patients With Chronic Sinusitis and Nasal Polyps

Condition:   Chronic Sinusitis
Interventions:   Drug: Hypertonic saline;   Drug: Fluticasone Nasal
Sponsor:   Assiut University

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

Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS

Condition:   Chronic Sinus Infection
Intervention:   Device: Sinopsys® Lacrimal Stent
Sponsor:   Sinopsys Surgical

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

480 Biomedical Sinus Drug Depot

Condition:   Chronic Sinusitis
Intervention:   Drug: 480 Mometasone Furoate Sinus Drug Depot
Sponsor:   480 Biomedical, Inc.

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

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

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

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

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: Nasonex steroid nasal spray
Sponsor:   Intersect ENT

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

Condition:   Chronic Sinusitis
Interventions:   Device: PROPEL Mini Sinus Implant.;   Procedure: Sinus Surgery alone;   Device: Propel Nova Sinus Implant
Sponsors:   Intersect ENT;   Advance Research Associates

Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia

Condition:   Chronic Sinusitis
Intervention:   Device: Propel Nova Sinus Implant
Sponsor:   Intersect ENT

Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia

Condition:   Chronic Sinusitis With Nasal Polyps and Eosinophilia
Intervention:   Drug: dexpramipexole
Sponsor:   Knopp Biosciences

Association of Periostin Levels and Chronic Sinusitis

Conditions:   Sinusitis;   Nasal Polyps
Intervention:   Other: Blood draw
Sponsor:   University of Virginia

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

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

Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery

Condition:   Chronic Sinusitis
Interventions:   Drug: Cocaine;   Drug: Adrenaline
Sponsor:   Marc Tewfik

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.

Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Conditions:   Chronic Sinusitis;   Polyposis
Intervention:   Drug: pulmicort
Sponsors:   University of Michigan;   American Rhinologic Society

Clinical Study to Improve Diagnosis and Treatment of Sinusitis

Condition:   Chronic Sinusitis
Sponsors:   Ohio State University;   National Institutes of Health (NIH);   National Center for Research Resources (NCRR)

Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

Condition:   Chronic Sinusitis
Intervention:   Device: Relieva™ Balloon Sinuplasty™ System
Sponsor:   Acclarent

Xylitol Versus Saline in Chronic Sinusitis

Condition:   Chronic Sinusitis
Interventions:   Drug: Xylitol;   Drug: Saline
Sponsor:   University of Iowa

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

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