Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux

This study has suspended participant recruitment.
(insufficient enrollment; study suspended pending analysis)
Sponsor:
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00451841
First received: March 22, 2007
Last updated: July 29, 2010
Last verified: July 2010

March 22, 2007
July 29, 2010
March 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00451841 on ClinicalTrials.gov Archive Site
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Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux
Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

frozen sputum supernatant and exhaled breath condensate fixed sputum cell preparations

Non-Probability Sample

Adult patients evaluated for cough in the Lung and Allergy Center of Umass Memorial Medical Center

  • Cough
  • Gastroesophageal Reflux
Device: RTube Exhaled Breath Condensate Collection System
Subjects breath through the device to collect exhaled breath condensate
  • 1
    Chronic cough caused by GERD
    Intervention: Device: RTube Exhaled Breath Condensate Collection System
  • 2
    Chronic cough without GERD
    Intervention: Device: RTube Exhaled Breath Condensate Collection System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
30
December 2012
Not Provided

Inclusion Criteria:

  • age > 18 years old
  • able to speak and read English
  • chronic cough

Exclusion Criteria:

  • Cigarette smoking within the past 6 months, or greater than 10 pack year history of prior smoking
  • Any self-reported or clinically diagnosed form of active lung disease, including asthma and emphysema
  • Symptoms of persistent rhinitis within the past three months
  • Dysphagia
  • Symptoms of acute viral upper respiratory tract infection or sinusitis within one month of entry into the study
  • Pregnancy - based on self report
  • Abnormal chest radiograph
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00451841
H-12073
No
Stephen Krinzmna MD, UMass Memorial Medical Center
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Stephen Krinzman, MD University of Massachusetts School of Medicine
University of Massachusetts, Worcester
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP