Serial Exhaled Breath pH Monitoring
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|ClinicalTrials.gov Identifier: NCT00330603|
Recruitment Status : Unknown
Verified March 2011 by University of Virginia.
Recruitment status was: Recruiting
First Posted : May 29, 2006
Last Update Posted : March 8, 2011
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|
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 Type :||Observational|
|Estimated Enrollment :||99 participants|
|Official Title:||Serial Exhaled Breath pH Monitoring|
|Study Start Date :||April 2006|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
- Procedure: Serial exhaled breath collections
collect breath for 5 minutes on 8 occasions
- pH of cough samples [ Time Frame: 1 month ]
- change in Leicester Cough Questionnaire (LCQ) total score [ Time Frame: 1 month ]
- proton pump inhibitor dosing [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330603
|Contact: John Hunt, MDfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: John Hunt, MD 434-243-9916 email@example.com|
|Principal Investigator: John Hunt, MD|
|Principal Investigator:||John Hunt, MD||University of Virginia|