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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
None posted in the registry

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.

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 groups in NCT02720653
Study groupRoleWhat they receive
Appropriate Medical TherapyPatients will self-select continued, non-standardized, appropriate medical management of symptoms associated with chronic sinusitis.
Endoscopic Sinus SurgeryPatients 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.

  1. Sniffin' Stick olfactory testing

    Improvement in olfactory function

    Measured: 6 months

Secondary outcomes (2)

  1. 22-Item Sinonasal Outcome Test

    Improvement in disease specific quality of life

    Measured: 6 months

  2. 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.

  1. First posted28 Mar 2016 (estimated)
  2. Study start1 Jul 2016
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

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)
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 41246125

  • Patel 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 40417805

  • Kallenberger 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 39761371

  • Gill 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 38367249

  • Hagedorn 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 37555485

  • Pandrangi 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 35938699

  • Gill 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 35511170

  • Allensworth 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 34762776

  • Soler 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 33549569

  • Beswick 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 32558260

  • Thomas 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 32017433

  • Beswick 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 31837149

  • Loftus 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 31603563

  • Beswick 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 31246360

  • Smith 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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Rhinosinusitis and Olfactory Dysfunction, run by Oregon Health and Science University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sniffin' Stick olfactory testing (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720653, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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