Chronic RhinosinusitisNCT02720653
Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis
An observational study of Chronic Rhinosinusitis and Olfactory Dysfunction, run by Oregon Health and Science University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Rhinosinusitis, Olfactory Dysfunction
- What is being tested?
- Endoscopic sinus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 418 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 Jun 2022
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present in clinic with indications of medically refractory chronic sinusitis.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Chronic Rhinosinusitis, Olfactory Dysfunction
- Being tested
- Endoscopic sinus surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sinus surgeryProcedure or surgery
Also called Sinus surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endoscopic sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sniffin' Stick olfactory testing
Improvement in olfactory function
Measured: 6 months
Secondary outcomes (2)
22-Item Sinonasal Outcome Test
Improvement in disease specific quality of life
Measured: 6 months
Questionnaire for Olfactory Dysfunction, QOD-NS
Improvement in olfactory specific quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Principal investigator, Dr. Timothy L. Smith, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720653
- Sponsor's protocol ID
- DC005805-11
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2016
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Tullis B, Mace JC, Massey C, Batterman S, Ramakrishnan VR, Beswick DM, Soler ZM, Smith TL, Alt JA, Gill AS. Pollen Exposure and Chronic Rhinosinusitis Quality of Life Disease Severity. Laryngoscope Investig Otolaryngol. 2025 Nov 13;10(6):e70309. doi: 10.1002/lio2.70309. eCollection 2025 Dec.
PubMed 41246125Patel PA, Kallenberger EM, Nguyen SA, Mace JC, Duffy AN, Soler ZM, Smith TL, Schlosser RJ. Factors Affecting Nasal Discharge in Chronic Rhinosinusitis Patients. Laryngoscope. 2025 Nov;135(11):4086-4092. doi: 10.1002/lary.32288. Epub 2025 May 26.
PubMed 40417805Kallenberger EM, Briggs EE, Nguyen SA, Ripp AT, Duffy AN, Schafer IV, Soler ZM, Mace JC, Smith TL, Schlosser RJ. Impact of Sinus Surgery on Nasal Discharge in Chronic Rhinosinusitis: A Systematic Review and Meta-Analysis. Int Forum Allergy Rhinol. 2025 Feb;15(2):174-184. doi: 10.1002/alr.23512. Epub 2025 Jan 6.
PubMed 39761371Gill AS, Tullis B, Mace JC, Massey C, Pandrangi VC, Gutierrez JA, Ramakrishnan VR, Beswick DM, Soler ZM, Smith TL, Alt JA. Health care disparities and chronic rhinosinusitis: Does neighborhood disadvantage impact outcomes in sinonasal disease? Int Forum Allergy Rhinol. 2024 Aug;14(8):1302-1313. doi: 10.1002/alr.23337. Epub 2024 Feb 17.
PubMed 38367249Hagedorn R, Tullis B, Nguyen C, Stockard R, Mace JC, Ramakrishnan VR, Beswick DM, Soler ZM, Smith TL, Alt JA, Gill AS. Does air pollutant exposure impact disease severity or outcomes in chronic rhinosinusitis? Int Forum Allergy Rhinol. 2024 Apr;14(4):755-764. doi: 10.1002/alr.23250. Epub 2023 Aug 15.
PubMed 37555485Pandrangi VC, Mace JC, Kim JH, Geltzeiler M, Detwiller KY, Soler ZM, Schlosser RJ, Alt JA, Ramakrishnan VR, Mattos JL, Smith TL. Work productivity and activity impairment in patients with chronic rhinosinusitis undergoing endoscopic sinus surgery-A prospective, multi-institutional study. Int Forum Allergy Rhinol. 2023 Mar;13(3):216-229. doi: 10.1002/alr.23070. Epub 2022 Aug 23.
PubMed 35938699Gill AS, Beswick DM, Mace JC, Menjivar D, Ashby S, Rimmer RA, Ramakrishnan VR, Soler ZM, Alt JA. Evaluating Distance Bias in Chronic Rhinosinusitis Outcomes. JAMA Otolaryngol Head Neck Surg. 2022 Jun 1;148(6):507-514. doi: 10.1001/jamaoto.2022.0268.
PubMed 35511170Allensworth JJ, Schlosser RJ, Smith TL, Mace JC, Soler ZM. Use of the Diet History Questionnaire III to determine the impact of dysosmia on dietary quality. Int Forum Allergy Rhinol. 2022 Jun;12(6):849-858. doi: 10.1002/alr.22926. Epub 2021 Dec 18.
PubMed 34762776Soler ZM, Schlosser RJ, Bodner TE, Alt JA, Ramakrishnan VR, Mattos JL, Mulligan JK, Mace JC, Smith TL. Endotyping chronic rhinosinusitis based on olfactory cleft mucus biomarkers. J Allergy Clin Immunol. 2021 May;147(5):1732-1741.e1. doi: 10.1016/j.jaci.2021.01.021. Epub 2021 Feb 4.
PubMed 33549569Beswick DM, Smith TL, Mace JC, Alt JA, Farrell NF, Ramakrishnan VR, Schlosser RJ, Soler ZM. Ethmoid-to-maxillary opacification ratio: a predictor of postoperative olfaction and outcomes in nasal polyposis? Int Forum Allergy Rhinol. 2021 Jan;11(1):48-57. doi: 10.1002/alr.22625. Epub 2020 Jun 18.
PubMed 32558260Thomas AJ, Mace JC, Ramakrishnan VR, Alt JA, Mattos JL, Schlosser RJ, Soler ZM, Smith TL. Quality-of-life and olfaction changes observed with short-term medical management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2020 May;10(5):656-664. doi: 10.1002/alr.22532. Epub 2020 Feb 3.
PubMed 32017433Beswick DM, Ayoub NF, Mace JC, Mowery A, Hwang PH, Smith TL. Acute Exacerbations in Recurrent Acute Rhinosinusitis: Differences in Quality of Life and Endoscopy. Laryngoscope. 2020 Dec;130(12):E736-E741. doi: 10.1002/lary.28460. Epub 2019 Dec 14.
PubMed 31837149Loftus C, Schlosser RJ, Smith TL, Alt JA, Ramakrishnan VR, Mattos JL, Mappus E, Storck K, Yoo F, Soler ZM. Olfactory cleft and sinus opacification differentially impact olfaction in chronic rhinosinusitis. Laryngoscope. 2020 Oct;130(10):2311-2318. doi: 10.1002/lary.28332. Epub 2019 Oct 11.
PubMed 31603563Beswick DM, Mace JC, Soler ZM, Rudmik L, Alt JA, Smith KA, Detwiller KY, Ramakrishnan VR, Smith TL. Socioeconomic status impacts postoperative productivity loss and health utility changes in refractory chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Sep;9(9):1000-1009. doi: 10.1002/alr.22374. Epub 2019 Jun 27.
PubMed 31246360Smith TL, Schlosser RJ, Mace JC, Alt JA, Beswick DM, DeConde AS, Detwiller KY, Mattos JL, Soler ZM. Long-term outcomes of endoscopic sinus surgery in the management of adult chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Aug;9(8):831-841. doi: 10.1002/alr.22369. Epub 2019 Jun 17.
PubMed 31207172