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Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02720653
First Posted: March 28, 2016
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Dr. Timothy L. Smith, Oregon Health and Science University
  Purpose
Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.

Condition Intervention
Chronic Rhinosinusitis Olfactory Dysfunction Procedure: Endoscopic sinus surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

Further study details as provided by Dr. Timothy L. Smith, Oregon Health and Science University:

Primary Outcome Measures:
  • Sniffin' Stick olfactory testing [ Time Frame: 6 months ]
    Improvement in olfactory function


Secondary Outcome Measures:
  • 22-Item Sinonasal Outcome Test [ Time Frame: 6 months ]
    Improvement in disease specific quality of life

  • Questionnaire for Olfactory Dysfunction, QOD-NS [ Time Frame: 6 months ]
    Improvement in olfactory specific quality of life


Biospecimen Retention:   Samples Without DNA
Mucus specimens will be collected and analyzed for cytokine profiles and proteomics

Estimated Enrollment: 1000
Study Start Date: July 2016
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Appropriate Medical Therapy
Patients will self-select continued, non-standardized, appropriate medical management of symptoms associated with chronic sinusitis.
Endoscopic Sinus Surgery
Patients will self-select endoscopic sinus surgery for symptoms associated with chronic sinusitis.
Procedure: Endoscopic sinus surgery
Other Name: Sinus surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present in clinic with indications of medically refractory chronic sinusitis.
Criteria

Inclusion Criteria:

  • Adult ( > 18 years of age)
  • A diagnosis of medical recalcitrant CRS as defined by 2015 Adult Sinusitis Guidelines outlined by the American Academy of Otolaryngology
  • Provide written informed consent and authorization.
  • Study participants must be able to complete consent, all study evaluations, olfactory testing, and study-related health questionnaires written in the English language.
  • Patients must self-select subsequent treatment option (endoscopic sinus surgery or continued medical therapy) to be dictated by the disease process and judgment and preferences of each individual, following counseling for each treatment option.
  • Present to the enrolling site with indication for a CT scan or a CT scan completed, off-site, from another provider
  • Complete appropriate standardized medical treatment by the Interim Assessment, 6-week follow-up period including, but not limited to, at least one course of either topical corticosteroids (>21-days) or a 5-day course of oral corticosteroid therapy, and at least one course (>14-days) of culture-directed or broad spectrum antibiotic therapy.

Exclusion Criteria:

  • Children (< 18 years of age)
  • Any patient unable and/or unwilling to complete questionnaires or clinical testing or cooperate with all study protocols.
  • Non-English speaking / English translation services required
  • Unwilling or unable to provide informed, written consent.
  • Contra-indications for any type of continued medical therapy required for treatment of symptoms related to CRS
  • Patients who have not undergone previous prescribed medical therapy as described in Inclusion Criteria.
  • Individuals of any vulnerable population including: children, pregnant women, neonates, decisionally impaired adults, or prisoners.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Timothy L. Smith, Professor, Chief of Rhinology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02720653     History of Changes
Other Study ID Numbers: DC005805-11
First Submitted: March 22, 2016
First Posted: March 28, 2016
Last Update Posted: January 11, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases