NCT02720653

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

6 years

First QC Date

March 22, 2016

Last Update Submit

April 19, 2022

Conditions

Chronic RhinosinusitisOlfactory Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Sniffin' Stick olfactory testing

    Improvement in olfactory function

    6 months

Secondary Outcomes (2)

  • 22-Item Sinonasal Outcome Test

    6 months

  • Questionnaire for Olfactory Dysfunction, QOD-NS

    6 months

Study Arms (2)

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

Interventions

Endoscopic sinus surgeryPROCEDURE
Also known as: Sinus surgery
Endoscopic Sinus Surgery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who present in clinic with indications of medically refractory chronic sinusitis.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Individuals of any vulnerable population including: children, pregnant women, neonates, decisionally impaired adults, or prisoners.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • 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.

    PMID: 41246125DERIVED

  • 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.

    PMID: 40417805DERIVED

  • 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.

    PMID: 35938699DERIVED

  • 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.

    PMID: 35511170DERIVED

  • 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.

    PMID: 34762776DERIVED

  • 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.

    PMID: 33549569DERIVED

  • 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.

    PMID: 32558260DERIVED

  • 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.

    PMID: 32017433DERIVED

  • 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.

    PMID: 31837149DERIVED

  • 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.

    PMID: 31603563DERIVED

  • 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.

    PMID: 31246360DERIVED

  • 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.

    PMID: 31207172DERIVED

  • Alt JA, Orlandi RR, Mace JC, Soler ZM, Smith TL. Does Delaying Endoscopic Sinus Surgery Adversely Impact Quality-of-Life Outcomes? Laryngoscope. 2019 Feb;129(2):303-311. doi: 10.1002/lary.27473. Epub 2018 Sep 12.

    PMID: 30208208DERIVED

  • Beswick DM, Mace JC, Rudmik L, Soler ZM, DeConde AS, Smith TL. Productivity changes following medical and surgical treatment of chronic rhinosinusitis by symptom domain. Int Forum Allergy Rhinol. 2018 Dec;8(12):1395-1405. doi: 10.1002/alr.22191. Epub 2018 Jul 28.

    PMID: 30054977DERIVED

  • Beswick DM, Mace JC, Soler ZM, Ayoub NF, Rudmik L, DeConde AS, Smith TL. Appropriateness criteria predict outcomes for sinus surgery and may aid in future patient selection. Laryngoscope. 2018 Nov;128(11):2448-2454. doi: 10.1002/lary.27227. Epub 2018 May 14.

    PMID: 29756211DERIVED

  • Mattos JL, Schlosser RJ, Mace JC, Smith TL, Soler ZM. Establishing the minimal clinically important difference for the Questionnaire of Olfactory Disorders. Int Forum Allergy Rhinol. 2018 Sep;8(9):1041-1046. doi: 10.1002/alr.22135. Epub 2018 May 2.

    PMID: 29719139DERIVED

  • Othieno F, Schlosser RJ, Rowan NR, Storck KA, Mattos JL, Smith TL, Soler ZM. Taste impairment in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018 Jul;8(7):783-789. doi: 10.1002/alr.22113. Epub 2018 Mar 23.

    PMID: 29569385DERIVED

  • Smith TL. THE 2017 13TH ANNUAL DAVID W. KENNEDY, MD, LECTURE The evolution of outcomes in sinus surgery for chronic rhinosinusitis: past, present, and future. Int Forum Allergy Rhinol. 2017 Dec;7(12):1121-1126. doi: 10.1002/alr.22026. Epub 2017 Oct 13.

    PMID: 29028274DERIVED

  • Beswick DM, Mace JC, Chowdhury NI, Alt JA, Hwang PH, DeConde AS, Smith TL. Comparison of surgical outcomes between patients with unilateral and bilateral chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Dec;7(12):1162-1169. doi: 10.1002/alr.22020. Epub 2017 Sep 22.

    PMID: 28941136DERIVED

  • DeConde AS, Mace JC, Ramakrishnan VR, Alt JA, Smith TL. Analysis of factors associated with electing endoscopic sinus surgery. Laryngoscope. 2018 Feb;128(2):304-310. doi: 10.1002/lary.26788. Epub 2017 Aug 4.

    PMID: 28776718DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mucus specimens will be collected and analyzed for cytokine profiles and proteomics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief of Rhinology

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 28, 2016

Study Start

July 1, 2016

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04