Alcohol Exposure and Airway Hyperresponsiveness
| Tracking Information | |||||
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| First Received Date ICMJE | October 2, 2009 | ||||
| Last Updated Date | August 30, 2011 | ||||
| Start Date ICMJE | October 2009 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness. [ Time Frame: 2 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00990275 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 | Alcohol Exposure and Airway Hyperresponsiveness | ||||
| Official Title ICMJE | Alcohol Exposure and Airway Hyperresponsiveness | ||||
| Brief Summary | Alcohol has well-established consequences in the lung including increased risk for upper respiratory tract infections, pneumonia and acute respiratory distress syndrome (ARDS). There have even been a few reports of alcohol-induced asthma. Data from the investigators' laboratory have established that the airways are specifically impacted by alcohol exposure. Because the airways are heavily exposed to the vapor phase of alcohol during drinking and airway motor tone is modulated by cAMP, the investigators speculated that airway bronchial motor function would be altered in mice fed alcohol. The investigators' preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (AHR) in a mouse model. This novel finding has led us to hypothesize that: Alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Other: ethanol
subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min. |
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| Study Arm (s) | Experimental: Post-alcohol
Intervention: Other: ethanol |
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| Publications * | Not Provided | ||||
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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 | 10 | ||||
| Estimated Completion Date | May 2012 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 21 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00990275 | ||||
| Other Study ID Numbers ICMJE | 268-07 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lisa Chudomelka, University of Nebraska | ||||
| Study Sponsor ICMJE | University of Nebraska | ||||
| Collaborators ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Nebraska | ||||
| Verification Date | August 2011 | ||||
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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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