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

University of Massachusetts, Worcester

Status: Terminated

Conditions: Gastroesophageal Reflux; Cough

Treatments: Device: RTube Exhaled Breath Condensate Collection System

Study type: Observational

Funder types: Other

Identifiers

NCT00451841

H-12073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

1

Description:

Chronic cough caused by GERD

Treatment:

Device: RTube Exhaled Breath Condensate Collection System

2

Description:

Chronic cough without GERD

Treatment:

Device: RTube Exhaled Breath Condensate Collection System