Oral Steroid Treatment for Chronic Rhinosinusitis
This study has been withdrawn prior to enrollment.
(Lack of proposed funding.)
Sponsor:
Oregon Health and Science University
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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 6, 2010 |
| Last Updated Date | April 7, 2011 |
| Start Date ICMJE | December 2010 |
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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. |
| Original Primary Outcome Measures ICMJE |
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 SNOT-22 and NOSE instruments. The SNOT-22 is a validated, 22-item outcome measure applicable to both sinonasal conditions and surgical treatments (score range: 0-110). Derived from the SNOT-20, two additional questions were added to measure nasal blockage and sense of taste/smell. 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. |
| Change History | Complete list of historical versions of study NCT01255683 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Oral Steroid Treatment for Chronic Rhinosinusitis |
| Official Title ICMJE | Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis |
| Brief Summary | 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). |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| 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). |
| Condition ICMJE | Chronic Rhinosinusitis |
| Intervention ICMJE | 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. |
| Study Group/Cohort (s) | Chronic rhinosinusitis
Intervention: Drug: oral corticosteroid taper |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Withdrawn |
| Estimated Enrollment ICMJE | 25 |
| Estimated Completion Date | November 2011 |
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01255683 |
| Other Study ID Numbers ICMJE | unfunded2 |
| Has Data Monitoring Committee | No |
| Responsible Party | Timothy L. Smith, MD, MPH, Oregon Health & Science University |
| Study Sponsor ICMJE | Oregon Health and Science University |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Oregon Health and Science University |
| Verification Date | December 2010 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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