Chronic RhinosinusitisNCT01255683
Oral Steroid Treatment for Chronic Rhinosinusitis
An observational study of Chronic Rhinosinusitis, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- oral corticosteroid taper
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Nov 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult study population with a confirmed diagnosis of chronic sinusitis presenting to the tertiary rhinology clinic at Oregon Health \& Science University (OHSU).
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis
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).
- Conditions
- Chronic Rhinosinusitis
- Being tested
- oral corticosteroid taper
- Keywords
- Chronic, Sinusitis, Steroid, treatment
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral corticosteroid taperDrug
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 | Role | What they receive |
|---|---|---|
| Chronic rhinosinusitis | Not described Receives: Drug: oral corticosteroid taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality-of-life
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.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Why it stopped: Lack of proposed funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255683
- Sponsor's protocol ID
- unfunded2
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2010
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT01255683
- Acronym / sponsor ID
- unfunded2
- Conditions
- Chronic Rhinosinusitis
- Keywords
- Chronic, Sinusitis, Steroid, treatment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of proposed funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic rhinosinusitis | – | Drug: oral corticosteroid taper |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult study population with a confirmed diagnosis of chronic sinusitis presenting to the tertiary rhinology clinic at Oregon Health \& Science University (OHSU).
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral corticosteroid taperThis is an observational study in which patients self-select oral steroid treatment for symptoms of CRS. Drug treatments are NOT assigned in this investigation. | Drug | Chronic rhinosinusitis |
Primary outcome
Health-related quality-of-life
Time frame: Change from baseline to 6 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
Related trials for Chronic Rhinosinusitis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Health-related quality-of-life (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2015.