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IRB approval not renewed/approval lapsed. Prior status: insufficient enrollment; study suspended pending analysis
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Chronic cough caused by GERD |
| |
| 2 | Chronic cough without GERD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTube Exhaled Breath Condensate Collection System | Device | Subjects breath through the device to collect exhaled breath condensate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of esophageal PH changes | Determine the sensitivity of esophageal PH changes between the group with GERD and the group without GERD. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients evaluated for cough in the Lung and Allergy Center of Umass Memorial Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Krinzman, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center, University Campus | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15223872 | Background | Niimi A, Nguyen LT, Usmani O, Mann B, Chung KF. Reduced pH and chloride levels in exhaled breath condensate of patients with chronic cough. Thorax. 2004 Jul;59(7):608-12. doi: 10.1136/thx.2003.012906. | |
| 16467175 | Background | Hunt J. Exhaled breath condensate pH: reflecting acidification of the airway at all levels. Am J Respir Crit Care Med. 2006 Feb 15;173(4):366-7. doi: 10.1164/rccm.2512001. No abstract available. |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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frozen sputum supernatant and exhaled breath condensate fixed sputum cell preparations
| 16135737 | Background | Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |