Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip
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| First Received Date ICMJE | December 25, 2007 | ||||
| Last Updated Date | March 8, 2010 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
We hypothesize that capsaicin cough sensitivity is increased in patients with PND-CC compared to subjects with PND without cough and that cough sensitivity to capsaicin will decrease with treatment for postnasal drip. [ Time Frame: Endpoint ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00588627 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip | ||||
| Official Title ICMJE | Capsaicin Cough Sensitivity, Airway Inflammation and Neurogenic Peptides in Chronic Cough Associated With Postnasal Drip | ||||
| Brief Summary | This study is being done to find out why some people with mucus dripping down the back of their throat have a nagging cough while others do not cough. |
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| Detailed Description | The objective of the protocol is to determine the pathogenesis of cough in diseases of the aerodigestive tract. There were over 24 million ambulatory chronic cough visits nationally in 1991 and over 8,000 visits in 2004 at MCR. Current guidelines for chronic cough are based on case series and on empirical expert opinions. Studies have implicated mucosal inflammation, heightened sensitivity of capsaicin cough receptors on peripheral nerves and elaboration of inflammatory mediators including tussigenic neuropeptides. There are gaps in our knowledge of what triggers cough in many disease states. For example, postnasal drip syndrome has been estimated to account for 70% of chronic cough, yet it is known that not all patients with postnasal drip have chronic cough. Our hypothesis is that there must be critical factor/s that cause cough in one patient with postnasal drip but not in another. This study will evaluate whether there exists differences in capsaicin cough sensitivity, neuropeptides levels and mucosal inflammation in patients with postnasal drip and chronic cough and compared to its natural control group, subjects with postnasal drip with and without chronic cough. After standard therapy to eliminate postnasal drip, repeat measurement of capsaicin sensitivity and nitric oxide levels will be obtained. There is a critical need to determine the mechanisms underlying cough for better management. The study results will provide insight and fill gaps in our knowledge and will serve to advance future work evaluating mechanisms of cough in other disease states including asthma, GERD, interstitial lung disease and smokers. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Mucus will be quantified and protease inhibitors will be added after collection. The specimen will be coded to deidentify. It will be transported to laboratory for storage and analysis. The mucus collected from the posterior nasopharynx will be frozen and assayed simultaneously. Substance P and Neurokinin A will be measured by ELISA at the end of the study period. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary care clinic, community samples |
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| Condition ICMJE | Post Nasal Drip | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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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 | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Postnasal Drip with chronic cough:
Exclusion Criteria:
Exclusion Criteria: Same for Post Nasal Drip without cough except:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00588627 | ||||
| Other Study ID Numbers ICMJE | 2251-05, CR-20 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kaiser G. Lim, MD, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | March 2010 | ||||
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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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