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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 17, 2008 | ||||||||
| Last Updated Date | January 8, 2009 | ||||||||
| Start Date ICMJE | July 2008 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00701207 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To determine if expression of α7 nAChR on monocytes/macrophages derived from the blood/lungs correlates with the severity of pulmonary sarcoidosis. [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Nicotine Patches in Patients With Sarcoidosis | ||||||||
| Official Title ICMJE | Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors | ||||||||
| Brief Summary | The purpose of this study is to compare peoples with disease (sarcoidosis) to those without disease. We want to see if people with sarcoidosis have a different immune response to those people without disease. The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis. |
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| Detailed Description | Until recently, there was no good explanation for the fact that smoking cigarettes actually reduces the risk of sarcoidosis. Research studies have shown that the nicotine, a common component of cigarette smoke, strongly suppresses the immune system and reduces the type of inflammation that is characteristic of sarcoidosis in the lungs. We propose that nicotine treatment, administered in the form of a skin patch, will reduce the severity of lung disease in patients with sarcoidosis. Sarcoidosis patients who volunteer to participate in this study will submit standardized questionnaires relating to their quality of life and the severity of their shortness of breath before and after treatment. We will also compare objective measures of lung function, radiographic parameters, and the severity of lung inflammation. We predict that nicotine treatment will reduce the severity of sarcoidosis symptoms, improve lung function, and resolve lung inflammation. If our hypothesis is proven to be correct in this relatively small group of patients, we will perform additional studies in a larger group of patients and will consider the features of sarcoidosis patients that predict a favorable response to nicotine and other nicotine-like drugs. If nicotine is ultimately found to be an effective treatment for sarcoidosis, it may replace some of the existing treatments which are frequently ineffective and have unacceptable side-effects. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Pulmonary Sarcoidosis | ||||||||
| Intervention ICMJE | Drug: nicotine patch | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 64 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00701207 | ||||||||
| Responsible Party | Elliott David Crouser, M.D./Primary Investigator, The Ohio State University | ||||||||
| Study ID Numbers ICMJE | 2008H0006, S-07-006 | ||||||||
| Study Sponsor ICMJE | Ohio State University | ||||||||
| Collaborators ICMJE | American Thoracic Society | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University | ||||||||
| Verification Date | January 2009 | ||||||||
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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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