AzTrials
AzTrials

Chronic RhinosinusitisNCT01332136

Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

An observational study of Chronic Rhinosinusitis, run by Oregon Health and Science University at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

This research study will be completed by enrolling a prospective, observational cohort study to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This investigation will compare quality of life outcomes between each treatment type, as well as measure cellular and molecular markers of… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Chronic Rhinosinusitis
How many people
966 participants
Where
1 siteUnited States
Study dates
Apr 2011to Mar 2016
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients who have failed intial medical management for chronic sinusitis and have presented to a tertiary care clinic for continued treatment.

Who may be able to join

  • Adult (>= 18 years)
  • Chronic rhinosinusitis as defined by the 2007 multi-disciplinary adult sinusitis guidelines
  • Able to complete all surveys/questionnaires in English
  • Persistent symptoms following initial medical management
  • Received at least 1 course of broad spectrum antibiotics or culture directed antibiotics for at least a total of 14 days
  • Received at least a 3 week trial of topical steroid sprays OR at least a 5 day trial of systemic corticosteroid therapy.
  • Counseled for subsequent treatment options including either medical management or endoscopic sinus surgery

Who cannot join

  • Children (<18 years)
  • Unable to complete all surveys/questionnaires at baseline

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

This research study will be completed by enrolling a prospective, observational cohort study to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This investigation will compare quality of life outcomes between each treatment type, as well as measure cellular and molecular markers of inflammation in the sinus mucosa, to create models that predict improvement in quality of life following treatment.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01332136
Study groupRoleWhat they receive
Endoscopic sinus surgeryPatients electing endoscopic sinus surgery for chronic rhinosinusitis
Medical managementContinued medical management for symptoms of chronic rhinosinusitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-specific quality of life

    Measured: 18 months post-treatment

Secondary outcomes (2)

  1. General health-related quality-of-life

    Measured: 18 months post-treatment

  2. Olfaction

    Measured: 18 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionMar 2016
  4. Study completionMar 2016

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
966 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01332136
Sponsor's protocol ID
2R01DC005805
Status last verified
Mar 2016
First submitted
7 Apr 2011
Last updated
29 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • Massey CJ, Humphries SM, Mace JC, Smith TL, Soler ZM, Ramakrishnan VR. Multi-institutional validation of an AI-based sinus CT analytic platform with olfactory assessments. Int Forum Allergy Rhinol. 2024 Nov;14(11):1806-1809. doi: 10.1002/alr.23410. Epub 2024 Jul 12.

    PubMed 38995344

  • Ramakrishnan VR, Arbet J, Mace JC, Suresh K, Shintani Smith S, Soler ZM, Smith TL. Predicting olfactory loss in chronic rhinosinusitis using machine learning. Chem Senses. 2021 Jan 1;46:bjab042. doi: 10.1093/chemse/bjab042.

    PubMed 34473227

  • Soudry E, Mace J, Smith TL, Hwang PH. Role of inferior turbinate reduction in the quality of life of patients undergoing endoscopic sinus surgery for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Aug;9(8):926-933. doi: 10.1002/alr.22356. Epub 2019 Jun 20.

    PubMed 31220413

  • Ramakrishnan VR, Mace JC, Soler ZM, Smith TL. Is greater antibiotic therapy prior to ESS associated with differences in surgical outcomes in CRS? Laryngoscope. 2019 Mar;129(3):558-566. doi: 10.1002/lary.27651. Epub 2018 Dec 24.

    PubMed 30582166

  • Chowdhury NI, Mace JC, Bodner TE, Alt JA, Deconde AS, Levy JM, Smith TL. Does Medical Therapy Improve SinoNasal Outcomes Test-22 Domain Scores? An Analysis of Clinically Important Differences. Laryngoscope. 2019 Jan;129(1):31-36. doi: 10.1002/lary.27470. Epub 2018 Sep 12.

    PubMed 30208209

  • 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.

    PubMed 29756211

  • Error M, Ashby S, Orlandi RR, Alt JA. Single-Blinded Prospective Implementation of a Preoperative Imaging Checklist for Endoscopic Sinus Surgery. Otolaryngol Head Neck Surg. 2018 Jan;158(1):177-180. doi: 10.1177/0194599817731740. Epub 2017 Sep 19.

    PubMed 28925320

  • 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.

    PubMed 28776718

  • Ramakrishnan VR, Mace JC, Soler ZM, Smith TL. Examination of high-antibiotic users in a multi-institutional cohort of chronic rhinosinusitis patients. Int Forum Allergy Rhinol. 2017 Apr;7(4):343-351. doi: 10.1002/alr.21903. Epub 2017 Jan 13.

    PubMed 28084683

  • DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017 Mar;127(3):550-555. doi: 10.1002/lary.26391. Epub 2016 Nov 12.

    PubMed 27859303

  • Steele TO, Buniel MC, Mace JC, El Rassi E, Smith TL. Lymphoma of the nasal cavity and paranasal sinuses: A case series. Am J Rhinol Allergy. 2016 Sep;30(5):335-9. doi: 10.2500/ajra.2016.30.4347.

    PubMed 27657899

  • Levy JM, Rudmik L, Peters AT, Wise SK, Rotenberg BW, Smith TL. Contemporary management of chronic rhinosinusitis with nasal polyposis in aspirin-exacerbated respiratory disease: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2016 Dec;6(12):1273-1283. doi: 10.1002/alr.21826. Epub 2016 Aug 2.

    PubMed 27480830

  • Falco JJ, Thomas AJ, Quin X, Ashby S, Mace JC, Deconde AS, Smith TL, Alt JA. Lack of correlation between patient reported location and severity of facial pain and radiographic burden of disease in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Nov;6(11):1173-1181. doi: 10.1002/alr.21797. Epub 2016 Jul 20.

    PubMed 27438938

  • Levy JM, Mace JC, Rudmik L, Soler ZM, Smith TL. Low 22-item sinonasal outcome test scores in chronic rhinosinusitis: Why do patients seek treatment? Laryngoscope. 2017 Jan;127(1):22-28. doi: 10.1002/lary.26157. Epub 2016 Jul 5.

    PubMed 27377575

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Rhinosinusitis, run by Oregon Health and Science University at 1 site in United States.

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 2 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 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Disease-specific quality of life (time frame: 18 months post-treatment). 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 NCT01332136, which also lists 51 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 29 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in