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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00451841
• Other study ID #: H-12073
• Status: Terminated
• Start date: March 2007
• Est. completion date: June 2013

Study information

• Verified date: June 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Gastroesophageal Reflux

Intervention

Device:
• RTube Exhaled Breath Condensate Collection System
Subjects breath through the device to collect exhaled breath condensate

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center, University Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (3)

Horváth I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jöbsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. — View Citation

Hunt J. Exhaled breath condensate pH: reflecting acidification of the airway at all levels. Am J Respir Crit Care Med. 2006 Feb 15;173(4):366-7. — View Citation

Niimi A, Nguyen LT, Usmani O, Mann B, Chung KF. Reduced pH and chloride levels in exhaled breath condensate of patients with chronic cough. Thorax. 2004 Jul;59(7):608-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of esophageal PH changes	Determine the sensitivity of esophageal PH changes between the group with GERD and the group without GERD.	24 hours