Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Phase 4NCT02119273
Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
A Phase 4 study testing Prednisone in people with Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), run by Loma Linda University at 1 site in United States.
Trial summary
Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 2018
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study.
- Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines.
- These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms.
- These symptoms must include at least one of the following:
- nasal obstruction
- rhinorrhea
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- postnasal drip.
- Additional symptoms can include facial pain/pressure or anosmia/hyposmia.
- These symptoms must be supplemented by either endoscopic signs of disease or characteristic CT changes.
- The presence or absence of nasal polyps defines the subtype (with polyps: CRSwNP; without polyps: CRSsNP).
Who cannot join
- Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings.
- Additionally, patients with known immunocompromise or mucociliary disorders will be excluded.
- Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda Sinus and Allergy Center
Redlands, California, 92374
About this study
Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for CRSsNP. The investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.
- Being tested
- Prednisone, Placebo
- Keywords
- CRSsNP, Steroids, Corticosteroids, Endoscopic, Surgery, Perioperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
See arm description
PlaceboDrug
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Steroid | Experimental | The steroid arm will take prednisone 10mg tabs starting 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days). Receives: Drug: Prednisone |
| Placebo | Placebo comparator | The placebo arm will receive placebo pills identical in appearance to prednisone 10mg pills. They will start taking them 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lund-Kennedy Endoscopy Score (LKES)
Objective endoscopic measure of sino-nasal mucosal health
Measured: 12 weeks
Secondary outcomes (4)
Sino-nasal Outcomes Test (SNOT-22)
Patient completed survey that objectifies sinonasal symptoms
Measured: 12 weeks
Boezaart bleeding score
Surgeon completed survey of bleeding during surgery
Measured: Day of surgery
Estimated blood loss
Estimation of blood lost during surgery, as reported by anesthesiologist
Measured: Day of surgery
Difficulty of surgery score
Surgeon completed survey of surgical difficulty
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Studies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Seiberling, MD, Loma Linda University
- Investigators
- Kristin Seiberling, MD, Principal investigator, Loma Linda Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119273
- Sponsor's protocol ID
- 5140031
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- ClinicalTrials.gov ID
- NCT02119273
- Acronym / sponsor ID
- 5140031
- Keywords
- CRSsNP, Steroids, Corticosteroids, Endoscopic, Surgery, Perioperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Apr 2014 (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.
Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for CRSsNP. The investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid | Experimental | Drug: PrednisoneThe steroid arm will take prednisone 10mg tabs starting 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days). |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo arm will receive placebo pills identical in appearance to prednisone 10mg pills. They will start taking them 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study.
- Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines.
- These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms.
- These symptoms must include at least one of the following:
- Additional symptoms can include facial pain/pressure or anosmia/hyposmia.
Key exclusion criteria (3 listed)
- Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings.
- Additionally, patients with known immunocompromise or mucociliary disorders will be excluded.
- Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.
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 |
|---|---|---|
| PrednisoneSee arm description | Drug | Steroid |
| PlaceboSee arm description | Drug | Placebo |
Primary outcome
Lund-Kennedy Endoscopy Score (LKES)
Time frame: 12 weeks
Objective endoscopic measure of sino-nasal mucosal health
4 secondary outcomes
Sino-nasal Outcomes Test (SNOT-22)
Time frame: 12 weeks
Boezaart bleeding score
Time frame: Day of surgery
Estimated blood loss
Time frame: Day of surgery
Difficulty of surgery score
Time frame: Day of surgery
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 28 Aug 2019.
Related trials for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Not yet recruitingObservational study
The German National CRS Registry (GenreCRS): Clinical Evaluation of the New European Academy for Allergy and Clinical Immunology (EAACI) Criteria for CRSwNP Disease Control, Remission and Cure in a Real-World Evidence Study Approach
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
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.
Kristin Seiberling, MD principal investigator
Loma Linda Department of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), run by Loma Linda 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 10 inclusion and 3 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 28 Aug 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lund-Kennedy Endoscopy Score (LKES) (time frame: 12 weeks). 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 28 Aug 2019.