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

This study is currently recruiting participants.
Verified by University of Massachusetts, September 2008

Sponsored by: University of Massachusetts
Information provided by: University of Massachusetts
ClinicalTrials.gov Identifier: NCT00451841
  Purpose

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   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux

Further study details as provided by University of Massachusetts:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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
Device: RTube Exhaled Breath Condensate Collection System
Subjects breath through the device to collect exhaled breath condensate
2
Chronic cough without GERD
Device: RTube Exhaled Breath Condensate Collection System
Subjects breath through the device to collect exhaled breath condensate

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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


Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451841

Contacts
Contact: Stephen Krinzman, MD     508-856-1975     krinzmas@ummhc.org    
Contact: Plutarco Castellanos, MD     508-856-1975    

Locations
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.            

Sponsors and Collaborators
University of Massachusetts

Investigators
Principal Investigator:     Stephen Krinzman, MD     University of Massachusetts School of Medicine    
  More Information


Publications:

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

Keywords provided by University of Massachusetts:
Cough  
Gastroesophageal reflux  
Exhaled breath condensate  

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Signs and Symptoms
Digestive System Diseases
Esophageal disorder
Respiratory Tract Diseases
Gastrointestinal Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Cough
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on September 19, 2008




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