Serial Exhaled Breath pH Monitoring

• ClinicalTrials.gov Identifier: NCT00330603
• Recruitment Status: Unknown
• First Posted: May 29, 2006
• Last Update Posted: March 8, 2011
• Sponsor: University of Virginia
• Information provided by: University of Virginia

Study Description

Brief Summary:

This study will seek to determine the amount of acids a person with a chronic cough that is suspected to be related to acid reflux breathes out after coughing. The study will also seek to determine if this measurement can predict the best treatment for the cough.

Subjects with a chronic cough which is suspected to be related to acid reflux for which their doctor has prescribed a proton pump inhibitor medication will be enrolled in this study.

Condition or disease	Intervention/treatment
Gastroesophageal Reflux	Procedure: Serial exhaled breath collections

Detailed Description:

Acid reflux has been considered to be a key contributor to cough, particularly in patients with obstructive lung diseases. However, diagnosis has relied upon either responsiveness to high dose twice daily administration of proton pump inhibitor therapy or by 24 hour esophageal pH probes. This study is designed to provide information for the development of a clinically useful diagnostic (exhaled breath condensate pH) to identify the contribution of acid reflux to cough.

Exhaled breath condensate (EBC) pH has been well documented to reflect airway acidification. Acid reflux to the level of the hypopharynx, which is a key common trigger of acid reflux induced cough, acidifies the airway sufficiently to be identified with EBC pH assays. The association of low EBC pH with an immediately preceding cough strongly suggests an association of the cough with an airway acid event, and even if the acidity is not prolonged, acid reflux becomes highly suspect.

This study will examine the ability of EBC pH measurements to prognose the likelihood of a positive response to acid blockade with proton pump inhibitor therapy in subjects with chronic cough.

Study Design

• Study Type: Observational
• Estimated Enrollment: 99 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Serial Exhaled Breath pH Monitoring
• Study Start Date: April 2006
• Estimated Primary Completion Date: December 2011
• Estimated Study Completion Date: December 2011

Groups and Cohorts

Intervention Details:

• Procedure: Serial exhaled breath collections
  collect breath for 5 minutes on 8 occasions

Outcome Measures

Primary Outcome Measures :

1. pH of cough samples [ Time Frame: 1 month ]
2. change in Leicester Cough Questionnaire (LCQ) total score [ Time Frame: 1 month ]

Secondary Outcome Measures :

1. proton pump inhibitor dosing [ Time Frame: 1 month ]

Eligibility Criteria

• Ages Eligible for Study: 5 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients with chronic cough for whom their doctor is planning to begin an empiric trial of proton pump inhibitor as a diagnostic trial of therapy.

Criteria

Inclusion Criteria:

• Outpatient
• 5 years of age and older
• Cough lasting a minimum of 3 weeks
• Has been prescribed a proton pump inhibitor as a single therapeutic and diagnostic effort to control the cough

Exclusion Criteria:

• Inability to perform serial exhaled breath condensate collections at home
• Unwillingness to initiate proton pump inhibitor therapy as prescribed by physician
• Other changes planned in therapy, such as initiating or discontinuing cough suppressant therapy, initiating or augmenting antibiotic therapy, initiating or augmenting anti-inflammatory therapy
• Previous treatment of respiratory symptoms with proton pump inhibitor therapy
• Current treatment with angiotensin converting enzyme inhibitor medication or H2 antagonists
• Regular exposure to an environmental irritant

Contacts and Locations

Contacts

Contact: John Hunt, MD; 434-243-9324; jfh2m@virginia.edu

Locations

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22908

Contact: John Hunt, MD 434-243-9916 jfh2m@virginia.edu

Principal Investigator: John Hunt, MD

Sponsors and Collaborators

University of Virginia

Investigators

• Principal Investigator: John Hunt, MD; University of Virginia

More Information

• Responsible Party: John Hunt, MD, University of Virginia, Pediatrics
• ClinicalTrials.gov Identifier: NCT00330603
• Other Study ID Numbers: 12302
• First Posted: May 29, 2006
• Last Update Posted: March 8, 2011
• Last Verified: March 2011

Keywords provided by University of Virginia:

Cough; Gastroesophageal Reflux

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases