Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451841
Status:
TERMINATED
Last Update Posted:
2018-06-26
First Post:
2007-03-22
Brief Title:
Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB approval not renewedapproval lapsed Prior status insufficient enrollment study suspended pending analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None