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Sponsored by: |
University of Massachusetts |
Information provided by: | University of Massachusetts |
ClinicalTrials.gov Identifier: | NCT00451841 |
Cough is the most common complaint for which patients seek medical attention in the United States, accounting for approximately 1 billion dollars in health care expenses annually. Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases. The majority of these patients with GERD-induced cough have no classic "heartburn" symptoms, so this important cause of cough can thus be difficult to detect.
Our hypothesis is that changes in exhaled breath condensate (EBC) pH can be used as a sensitive and non-invasive marker to identify subjects with cough caused by acid reflux.
Condition | Intervention |
Cough Gastroesophageal Reflux |
Device: RTube Exhaled Breath Condensate Collection System |
MedlinePlus related topics: | Cough GERD |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux |
frozen sputum supernatant and exhaled breath condensate fixed sputum cell preparations
Estimated Enrollment: | 30 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2008 |
Groups/Cohorts | Assigned Interventions |
1
Chronic cough caused by GERD
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Device: RTube Exhaled Breath Condensate Collection System
Subjects breath through the device to collect exhaled breath condensate
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2
Chronic cough without GERD
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Device: RTube Exhaled Breath Condensate Collection System
Subjects breath through the device to collect exhaled breath condensate
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Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases, and majority of these patients with GERD-induced cough have no classic "heartburn" symptoms. This important cause of cough can thus be difficult to detect. Non-invasive radiologic tests for GERD such as barium swallow is imperfectly sensitive in subjects with GERD-induced cough. The 24 hour pH probe, which continuously monitors esophageal pH and can correlate cough events with reflux events, is considered to be the gold standard test. However, this test is expensive, invasive, and not universally available.
The goal of the current study is to compare simultaneous measurements of esophageal pH with exhaled breath condensate pH after cough episodes, in patients with symptomatic cough. The cause of cough will be determined by a standard protocol, which includes 24 hour pH probe studies, and assessment for asthma, upper airway causes and sinus disease, and medication effects. All subjects will undergo 24 hour pH monitoring. During this monitoring period, they press an event button on the pH recording device to indicate a cough episode. After six such events, they will immediately perform an EBC collection, and EBC pH will subsequently be analyzed. Differences between pH changes in the group with cough cause by GERD will be compared to pH measurements in the group with cough but no GERD, to determine the sensitivity and specificity of pH changes for discriminating between the two groups, and optimal threshold values for pH changes in EBC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adult patients evaluated for cough in the Lung and Allergy Center of Umass Memorial Medical Center
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephen Krinzman, MD | 508-856-1975 | krinzmas@ummhc.org |
Contact: Plutarco Castellanos, MD | 508-856-1975 |
United States, Massachusetts | |||||
UMass Memorial Medical Center, University Campus | Recruiting | ||||
Worcester, Massachusetts, United States, 01655 | |||||
Sub-Investigator: Plutarco Castellanos, MD | |||||
Sub-Investigator: Scott Kopec, MD | |||||
Sub-Investigator: Richard Irwin, MD | |||||
Sub-Investigator: Gayle Clemons, NP | |||||
Sub-Investigator: Cynthia French, NP | |||||
Sub-Investigator: Fran Okulicz, R.T. |
University of Massachusetts |
Principal Investigator: | Stephen Krinzman, MD | University of Massachusetts School of Medicine |
Responsible Party: | UMass Memorial Medical Center ( Stephen Krinzmna MD ) |
Study ID Numbers: | H-12073 |
First Received: | March 22, 2007 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00451841 |
Health Authority: | United States: Institutional Review Board |
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