Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by Northwestern University
Sponsor:
Northwestern University
Collaborator:
Information provided by (Responsible Party):
Robert Schleimer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00841802
First received: February 9, 2009
Last updated: December 2, 2014
Last verified: December 2014
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| First Received Date ICMJE | February 9, 2009 | ||||||||
| Last Updated Date | December 2, 2014 | ||||||||
| Start Date ICMJE | July 2008 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00841802 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 | Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study | ||||||||
| Official Title ICMJE | Glucocorticosteroid Action in Inflammatory Disease | ||||||||
| Brief 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. 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. |
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| 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
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Prednisone
Prednisone 30mg once daily x 5 days
Other Names:
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | June 2015 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00841802 | ||||||||
| Other Study ID Numbers ICMJE | STU00010040, 5R37HL068546 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Robert Schleimer, Northwestern University | ||||||||
| Study Sponsor ICMJE | Northwestern University | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||||||
| Verification Date | December 2014 | ||||||||
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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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