Gastroesophageal Reflux Clinical Trial
Official title:
Serial Exhaled Breath pH Monitoring
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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