NCT02748070

Brief Summary

While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 24, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

4 years

First QC Date

April 15, 2016

Results QC Date

July 13, 2020

Last Update Submit

July 23, 2020

Conditions

Chronic RhinosinusitisEndoscopic Sinus SurgeryChronic Rhinosinusitis Without PolypsOral Steroids

Outcome Measures

Primary Outcomes (2)

  • Sino-nasal Outcome Test (SNOT-22) Over Time

    SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.

    Baseline, 1, week, 1 month, 3 months, and 6 months

  • Lund Kennedy Endoscopy Score Over Time

    The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance.

    Baseline, 1, week, 1 month, 3 months, and 6 months

Study Arms (2)

Prednisone

EXPERIMENTAL

Provided oral steroid and topical steroid

Drug: PrednisoneDrug: Flonase

Placebo

PLACEBO COMPARATOR

Provided oral placebo and topical steroid

Drug: Flonase

Interventions

PrednisoneDRUG
Prednisone
FlonaseDRUG
PlaceboPrednisone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
  • scheduled to undergo endoscopic sinus surgery

You may not qualify if:

  • chronic rhinosinusitis with polyps (CRSwNP)
  • Aspirin exacerbated respiratory disease
  • Cystic fibrosis
  • Immunosuppressive states (Human immunodeficiency virus, transplant)
  • Oral steroid use within 30 days of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Chang MT, Noel J, Ayoub NF, Qian ZJ, Dholakia S, Nayak JV, Patel ZM, Hwang PH. Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):434-441. doi: 10.1001/jamaoto.2021.0011.

    PMID: 33662124DERIVED

MeSH Terms

Interventions

PrednisoneFluticasone

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAndrostadienesAndrostenesAndrostanes

Results Point of Contact

Title
Michael Chang
Organization
Stanford University
michael.t.chang@stanford.edu
(650) 725-6500

Study Officials

  • Julia E Noel, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Michael T Chang, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Peter H Hwang, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 22, 2016

Study Start

August 1, 2015

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

August 4, 2020

Results First Posted

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)