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| Sponsored by: |
University of Virginia |
|---|---|
| Information provided by: | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00330603 |
Purpose
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 | Intervention |
|---|---|
|
Gastroesophageal Reflux |
Procedure: Serial exhaled breath collections |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Serial Exhaled Breath pH Monitoring |
| Estimated Enrollment: | 99 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John Hunt, MD | 434-243-9324 | jfh2m@virginia.edu |
| 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 | |
| Principal Investigator: | John Hunt, MD | University of Virginia |
More Information
| Responsible Party: | University of Virginia, Pediatrics ( John Hunt, MD ) |
| Study ID Numbers: | 12302 |
| Study First Received: | May 26, 2006 |
| Last Updated: | September 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00330603 |
| Health Authority: | United States: Institutional Review Board |
|
Cough Gastroesophageal Reflux |
|
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Cough Esophageal Diseases Gastroesophageal Reflux |
