Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
This study has been terminated.
(Study stopped early due to slow accrual.)
Sponsor:
University of Chicago
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Jayant Pinto, University of Chicago
ClinicalTrials.gov Identifier:
NCT00361439
First received: August 4, 2006
Last updated: December 14, 2012
Last verified: December 2012
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| Tracking Information | |||||
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| First Received Date ICMJE | August 4, 2006 | ||||
| Last Updated Date | December 14, 2012 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Histological Findings [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported |
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| Original Primary Outcome Measures ICMJE |
Nasal inflammation | ||||
| Change History | Complete list of historical versions of study NCT00361439 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis | ||||
| Official Title ICMJE | Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis | ||||
| Brief Summary | People with allergies frequently complain of a loss or reduction in the sense of smell. In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Seasonal Allergic Rhinitis | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Sivam A, Jeswani S, Reder L, Wang J, DeTineo M, Taxy J, Baroody FM, Naclerio RM, Pinto JM. Olfactory cleft inflammation is present in seasonal allergic rhinitis and is reduced with intranasal steroids. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):286-90. | ||||
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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 | Terminated | ||||
| Enrollment ICMJE | 17 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | September 2008 (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 59 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00361439 | ||||
| Other Study ID Numbers ICMJE | 14757A (P04908), IRB #14757A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jayant Pinto, University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Schering-Plough | ||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||
| Verification Date | December 2012 | ||||
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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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