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Oral Steroid Treatment for Chronic Rhinosinusitis

This study has been withdrawn prior to enrollment.
(Lack of proposed funding.)
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01255683
First received: December 6, 2010
Last updated: April 7, 2011
Last verified: December 2010
History of Changes
  Purpose

Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS), the natural history and efficacy of this treatment modality has not been fully elucidated. Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural history of endoscopic improvement and quality of life (QoL) outcomes, following an oral steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic grading, QoL, and olfactory function as well as defining the duration of improvement, in patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).


Condition Intervention
Chronic Rhinosinusitis
 Drug: oral corticosteroid taper

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Health-related quality-of-life [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
    The two main outcome measures to evaluate changes in QoL include the Sinonasal Outcome Test-22 (SNOT-22) and Nasal Obstruction Scoring Evaluation (NOSE) instruments. The SNOT-22 is a validated, 22-item outcome measure applicable to both sinonasal conditions and surgical treatments (score range: 0-110). Lower total scores on the SNOT-22 imply better QoL. The SNOT-22 will be administered by the Study Coordinator to study participants at baseline, as well as 2 week, 1 month, 3 month, and 6 month follow-up appointments.


Estimated Enrollment: 25
Study Start Date: December 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic rhinosinusitis Drug: oral corticosteroid taper
This is an observational study in which patients self-select oral steroid treatment for symptoms of CRS. Drug treatments are NOT assigned in this investigation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult study population with a confirmed diagnosis of chronic sinusitis presenting to the tertiary rhinology clinic at Oregon Health & Science University (OHSU).

Criteria

Inclusion Criteria:

  • Adult ( > 18 years of age)
  • CRS defined by 2007 Adult Sinusitis Guidelines.12
  • Subject must be able to complete QoL questionnaires written in English
  • Previous sinus surgery including unilateral or bilateral total ethmoidectomy
  • Minimum nasal blockage score on SinoNasal Outcomes Test-22 (SNOT-22) > 3
  • Severe sinonasal inflammation where the next treatment option is a 12- day oral prednisone taper
  • Obstruction of the ethmoid sinus region or middle meatus eligible for revision endoscopic sinus surgery
  • Lund-Kennedy endoscopy score > 4
  • Elects 12-day tapering dose of oral steroids (Prednisone) as a next treatment option

Exclusion Criteria:

  • Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English
  • Contra-indication to oral steroids
  • Endoscopic sinus surgery < 3 months of presentation
  • Completed course of oral corticosteroids within the previous 3 month period
  • Subjects presenting with unilateral chronic rhinosinusitis
  • Pregnancy or possibility to become pregnant during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255683

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Timothy L. Smith, MD, MPH, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01255683     History of Changes
Other Study ID Numbers: unfunded2
Study First Received: December 6, 2010
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Chronic
Sinusitis
Steroid
treatment

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013