Chronic SinusitisPhase 4NCT00841802
Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
A Phase 4 study testing Prednisone in people with Chronic Sinusitis and Rhinosinusitis, run by Northwestern University at 1 site in United States.
Trial summary
This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinusitis, Rhinosinusitis, Nasal Polyps
- What is being tested?
- Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 30 Jun 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 years to 70 years
- Diagnosis of chronic rhinosinusitis (CRS) with nasal polyps (NP) and will be undergoing sinonasal surgery for this condition
- Diagnosis of CRS without NP and will be undergoing sinonasal surgery for this condition
- No diagnosis of CRS and NP and will be undergoing nasal surgery (septoplasty/rhinoplasty, nasal fracture repair,etc.)
Who cannot join
- Ages younger than 18 years and ages older than 70 years
- Diagnosis of an established immunodeficiency, pregnancy, coagulation disorder, a diagnosis of allergic fungal sinusitis (AFS), or cystic fibrosis
- Those with CRS with or without NP in whom systemic steroid therapy would be contraindicated
- Those who are dependent on systemic steroid therapy for sinonasal disease or any other condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucocorticosteroid Action in Inflammatory Disease
This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. However, it is not well known exactly which patients will benefit from steroids when used in the treatment of chronic sinusitis. For some doctors, it is common practice to use these medications prior to planned sinus surgery, to lessen the inflammation and possibly help the healing process. Other doctors feel oral steroids may not be helpful in this way, and there is no conclusive data as to whether this practice has a long term benefit.
Read the detailed description
The purpose of this research study is to better understand how this potential treatment option, oral steroids, affects biochemical substances that have been associated with the development of chronic sinusitis and polyps. In order to do this, we need to study people with different forms of chronic sinusitis and compare them to individuals without allergies or sinus disease. We will also look at patients with chronic sinusitis who are treated with oral steroids and compare them to chronic sinus patients who have not received oral steroid therapy prior to surgery. This study may help pave the way to new treatments that address specific parts of the chronic sinus inflammatory pathway.
Hypotheses
- Oral steroid treatment of patients with CRS will lead to a correction in the inflammation that is observed in sinonasal tissues, nasal brushings, and nasal lavage.
- Steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps.
- Changes in inflammation will correlate with clinical variables.
- Conditions
- Chronic Sinusitis, Rhinosinusitis, Nasal Polyps
- Being tested
- Prednisone
- Keywords
- Chronic sinusitis, Chronic rhinosinusitis, Nasal polyps
- Medical subject headings
- Rhinosinusitis, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Glucocorticoid, Deltasone, Liquid Pred, Meticorten
Prednisone 30mg once daily x 5 days
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | Steroid medication Receives: Drug: Prednisone |
| No Intervention | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations of inflammatory cells, levels of key antibodies and cytokines, and expression of key epithelial genes
Measured: Prior to surgery and steroid treatment and day of surgery w/ or w/o having been treated w/ steroids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJul 2008
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Realized there was a design flaw.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert Schleimer, Northwestern University
- Investigators
- Robert P Schleimer, PhD, Principal investigator, Northwestern University and Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841802
- Sponsor's protocol ID
- STU00010040
- Other IDs
- 5R37HL068546
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2009
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Zele T, Claeys S, Gevaert P, Van Maele G, Holtappels G, Van Cauwenberge P, Bachert C. Differentiation of chronic sinus diseases by measurement of inflammatory mediators. Allergy. 2006 Nov;61(11):1280-9. doi: 10.1111/j.1398-9995.2006.01225.x.
PubMed 17002703Kanai N, Denburg J, Jordana M, Dolovich J. Nasal polyp inflammation. Effect of topical nasal steroid. Am J Respir Crit Care Med. 1994 Oct;150(4):1094-100. doi: 10.1164/ajrccm.150.4.7921442.
PubMed 7921442Lavigne F, Cameron L, Renzi PM, Planet JF, Christodoulopoulos P, Lamkioued B, Hamid Q. Intrasinus administration of topical budesonide to allergic patients with chronic rhinosinusitis following surgery. Laryngoscope. 2002 May;112(5):858-64. doi: 10.1097/00005537-200205000-00015.
PubMed 12150618Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.
PubMed 18075447Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, Adinoff AD, Bachert C, Borish L, Chinchilli VM, Danzig MR, Ferguson BJ, Fokkens WJ, Jenkins SG, Lund VJ, Mafee MF, Naclerio RM, Pawankar R, Ponikau JU, Schubert MS, Slavin RG, Stewart MG, Togias A, Wald ER, Winther B; Rhinosinusitis Initiative. Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006 Nov;118(5 Suppl):S17-61. doi: 10.1016/j.jaci.2006.09.005.
PubMed 17084217Richer SL, Truong-Tran AQ, Conley DB, Carter R, Vermylen D, Grammer LC, Peters AT, Chandra RK, Harris KE, Kern RC, Schleimer RP. Epithelial genes in chronic rhinosinusitis with and without nasal polyps. Am J Rhinol. 2008 May-Jun;22(3):228-34. doi: 10.2500/ajr.2008.22.3162.
PubMed 18588753Kato A, Peters A, Suh L, Carter R, Harris KE, Chandra R, Conley D, Grammer LC, Kern R, Schleimer RP. Evidence of a role for B cell-activating factor of the TNF family in the pathogenesis of chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2008 Jun;121(6):1385-92, 1392.e1-2. doi: 10.1016/j.jaci.2008.03.002. Epub 2008 Apr 14.
PubMed 18410958Xu G, Mou Z, Jiang H, Cheng L, Shi J, Xu R, Oh Y, Li H. A possible role of CD4+CD25+ T cells as well as transcription factor Foxp3 in the dysregulation of allergic rhinitis. Laryngoscope. 2007 May;117(5):876-80. doi: 10.1097/MLG.0b013e318033f99a.
PubMed 17473687Schleimer RP, Kato A, Kern R, Kuperman D, Avila PC. Epithelium: at the interface of innate and adaptive immune responses. J Allergy Clin Immunol. 2007 Dec;120(6):1279-84. doi: 10.1016/j.jaci.2007.08.046. Epub 2007 Oct 18.
PubMed 17949801Kato A, Schleimer RP. Beyond inflammation: airway epithelial cells are at the interface of innate and adaptive immunity. Curr Opin Immunol. 2007 Dec;19(6):711-20. doi: 10.1016/j.coi.2007.08.004. Epub 2007 Oct 24.
PubMed 17928212Kato A, Favoreto S Jr, Avila PC, Schleimer RP. TLR3- and Th2 cytokine-dependent production of thymic stromal lymphopoietin in human airway epithelial cells. J Immunol. 2007 Jul 15;179(2):1080-7. doi: 10.4049/jimmunol.179.2.1080.
PubMed 17617600Schleimer RP, Lane AP, Kim J. Innate and acquired immunity and epithelial cell function in chronic rhinosinusitis. Clin Allergy Immunol. 2007;20:51-78.
PubMed 17534045Kato A, Truong-Tran AQ, Scott AL, Matsumoto K, Schleimer RP. Airway epithelial cells produce B cell-activating factor of TNF family by an IFN-beta-dependent mechanism. J Immunol. 2006 Nov 15;177(10):7164-72. doi: 10.4049/jimmunol.177.10.7164.
PubMed 17082634Conley DB, Tripathi A, Seiberling KA, Schleimer RP, Suh LA, Harris K, Paniagua MC, Grammer LC, Kern RC. Superantigens and chronic rhinosinusitis: skewing of T-cell receptor V beta-distributions in polyp-derived CD4+ and CD8+ T cells. Am J Rhinol. 2006 Sep-Oct;20(5):534-9. doi: 10.2500/ajr.2006.20.2941.
PubMed 17063750Lane AP, Truong-Tran QA, Schleimer RP. Altered expression of genes associated with innate immunity and inflammation in recalcitrant rhinosinusitis with polyps. Am J Rhinol. 2006 Mar-Apr;20(2):138-44.
PubMed 16686375
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticosteroid Action in Inflammatory Disease
- ClinicalTrials.gov ID
- NCT00841802
- Acronym / sponsor ID
- STU00010040
- Conditions
- Chronic Sinusitis, Rhinosinusitis, Nasal Polyps
- Keywords
- Chronic sinusitis, Chronic rhinosinusitis, Nasal polyps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Realized there was a design flaw.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2008
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 11 Feb 2009 (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.
This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. However, it is not well known exactly which patients will benefit from steroids when used in the treatment of chronic sinusitis. For some doctors, it is common practice to use these medications prior to planned sinus surgery, to lessen the inflammation and possibly help the healing process. Other doctors feel oral steroids may not be helpful in this way, and there is no conclusive data as to whether this practice has a long term benefit.
Detailed description
The purpose of this research study is to better understand how this potential treatment option, oral steroids, affects biochemical substances that have been associated with the development of chronic sinusitis and polyps. In order to do this, we need to study people with different forms of chronic sinusitis and compare them to individuals without allergies or sinus disease. We will also look at patients with chronic sinusitis who are treated with oral steroids and compare them to chronic sinus patients who have not received oral steroid therapy prior to surgery. This study may help pave the way to new treatments that address specific parts of the chronic sinus inflammatory pathway.
Hypotheses
- Oral steroid treatment of patients with CRS will lead to a correction in the inflammation that is observed in sinonasal tissues, nasal brushings, and nasal lavage.
- Steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps.
- Changes in inflammation will correlate with clinical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: PrednisoneSteroid medication |
| No Intervention | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 years to 70 years
- Diagnosis of chronic rhinosinusitis (CRS) with nasal polyps (NP) and will be undergoing sinonasal surgery for this condition
- Diagnosis of CRS without NP and will be undergoing sinonasal surgery for this condition
- No diagnosis of CRS and NP and will be undergoing nasal surgery (septoplasty/rhinoplasty, nasal fracture repair,etc.)
Key exclusion criteria (4 listed)
- Ages younger than 18 years and ages older than 70 years
- Diagnosis of an established immunodeficiency, pregnancy, coagulation disorder, a diagnosis of allergic fungal sinusitis (AFS), or cystic fibrosis
- Those with CRS with or without NP in whom systemic steroid therapy would be contraindicated
- Those who are dependent on systemic steroid therapy for sinonasal disease or any other condition
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 |
|---|---|---|
| PrednisoneAlso: Glucocorticoid, Deltasone, Liquid Pred, MeticortenPrednisone 30mg once daily x 5 days | Drug | Prednisone |
Primary outcome
Alterations of inflammatory cells, levels of key antibodies and cytokines, and expression of key epithelial genes
Time frame: Prior to surgery and steroid treatment and day of surgery w/ or w/o having been treated w/ steroids
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 2 Apr 2020.
- Background: PubMed 17002703Van Zele T, Claeys S, Gevaert P, Van Maele G, Holtappels G, Van Cauwenberge P, Bachert C. Differentiation of chronic sinus diseases by measurement of inflammatory mediators. Allergy. 2006 Nov;61(11):1280-9. doi: 10.1111/j.1398-9995.2006.01225.x.
- Background: PubMed 7921442Kanai N, Denburg J, Jordana M, Dolovich J. Nasal polyp inflammation. Effect of topical nasal steroid. Am J Respir Crit Care Med. 1994 Oct;150(4):1094-100. doi: 10.1164/ajrccm.150.4.7921442.
- Background: PubMed 12150618Lavigne F, Cameron L, Renzi PM, Planet JF, Christodoulopoulos P, Lamkioued B, Hamid Q. Intrasinus administration of topical budesonide to allergic patients with chronic rhinosinusitis following surgery. Laryngoscope. 2002 May;112(5):858-64. doi: 10.1097/00005537-200205000-00015.
- Background: PubMed 18075447Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.
- Background: PubMed 17084217Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, Adinoff AD, Bachert C, Borish L, Chinchilli VM, Danzig MR, Ferguson BJ, Fokkens WJ, Jenkins SG, Lund VJ, Mafee MF, Naclerio RM, Pawankar R, Ponikau JU, Schubert MS, Slavin RG, Stewart MG, Togias A, Wald ER, Winther B; Rhinosinusitis Initiative. Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006 Nov;118(5 Suppl):S17-61. doi: 10.1016/j.jaci.2006.09.005.
- Background: PubMed 18588753Richer SL, Truong-Tran AQ, Conley DB, Carter R, Vermylen D, Grammer LC, Peters AT, Chandra RK, Harris KE, Kern RC, Schleimer RP. Epithelial genes in chronic rhinosinusitis with and without nasal polyps. Am J Rhinol. 2008 May-Jun;22(3):228-34. doi: 10.2500/ajr.2008.22.3162.
- Background: PubMed 18410958Kato A, Peters A, Suh L, Carter R, Harris KE, Chandra R, Conley D, Grammer LC, Kern R, Schleimer RP. Evidence of a role for B cell-activating factor of the TNF family in the pathogenesis of chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2008 Jun;121(6):1385-92, 1392.e1-2. doi: 10.1016/j.jaci.2008.03.002. Epub 2008 Apr 14.
- Background: PubMed 17473687Xu G, Mou Z, Jiang H, Cheng L, Shi J, Xu R, Oh Y, Li H. A possible role of CD4+CD25+ T cells as well as transcription factor Foxp3 in the dysregulation of allergic rhinitis. Laryngoscope. 2007 May;117(5):876-80. doi: 10.1097/MLG.0b013e318033f99a.
- Background: PubMed 17949801Schleimer RP, Kato A, Kern R, Kuperman D, Avila PC. Epithelium: at the interface of innate and adaptive immune responses. J Allergy Clin Immunol. 2007 Dec;120(6):1279-84. doi: 10.1016/j.jaci.2007.08.046. Epub 2007 Oct 18.
- Background: PubMed 17928212Kato A, Schleimer RP. Beyond inflammation: airway epithelial cells are at the interface of innate and adaptive immunity. Curr Opin Immunol. 2007 Dec;19(6):711-20. doi: 10.1016/j.coi.2007.08.004. Epub 2007 Oct 24.
- Background: PubMed 17617600Kato A, Favoreto S Jr, Avila PC, Schleimer RP. TLR3- and Th2 cytokine-dependent production of thymic stromal lymphopoietin in human airway epithelial cells. J Immunol. 2007 Jul 15;179(2):1080-7. doi: 10.4049/jimmunol.179.2.1080.
- Background: PubMed 17534045Schleimer RP, Lane AP, Kim J. Innate and acquired immunity and epithelial cell function in chronic rhinosinusitis. Clin Allergy Immunol. 2007;20:51-78.
- Principal Investigator SiteLink provided by the sponsor.
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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.
Robert P Schleimer, PhD principal investigator
Northwestern University and Northwestern Memorial Hospital
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 Sinusitis and Rhinosinusitis, run by Northwestern 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 4 inclusion and 4 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 2 Apr 2020. 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.
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?
Alterations of inflammatory cells, levels of key antibodies and cytokines, and expression of key epithelial genes (time frame: Prior to surgery and steroid treatment and day of surgery w/ or w/o having been treated w/ steroids). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841802, which also lists 19 linked publications.
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 2 Apr 2020.