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
  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

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

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Biospecimen Retention:   Samples Without DNA

frozen sputum supernatant and exhaled breath condensate fixed sputum cell preparations


Estimated Enrollment: 30
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
UMass Memorial Medical Center, University Campus
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Stephen Krinzman, MD University of Massachusetts School of Medicine
  More Information

Publications:
Responsible Party: Stephen Krinzmna MD, UMass Memorial Medical Center
ClinicalTrials.gov Identifier: NCT00451841     History of Changes
Other Study ID Numbers: H-12073
Study First Received: March 22, 2007
Last Updated: July 29, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cough
Gastroesophageal Reflux
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014