Cough Clinical Trial
Official title:
Chronic Cough and Reflux Disease: A Randomized, Double-Blinded, Placebo Controlled Trial of High Dose Proton Pump Inhibition
The purpose of this research study is to investigate different doses of proton pump
inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux
disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by
lowering the amount of acid in the stomach.
The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium),
and is already marketed for treating GERD. Patients with GERD may experience all or some of
the following symptoms: stomach acid or partially digested food re-entering the esophagus
(which is sometimes referred to as heartburn or regurgitation), belching and coughing. Even
very small, unnoticeable amounts of rising stomach acid may cause patients to cough.
Because there may be a link between chronic cough and GERD, study doctors are interested in
learning if giving high-dose Nexium (40 milligrams, twice daily) will help in treating
chronic cough.
This study will be a randomized, double-blind, placebo controlled, comparative
parallel-group trial of subjects with chronic cough of unknown origin presenting to the
Otolaryngology/ Head and Neck Surgery, Pulmonary Medicine, and Gastroenterology outpatient
clinics at the University of North Carolina Hospital system.
Potential subjects with chronic cough of unknown origin will be identified through the above
outpatient clinics. Those who meet the inclusion and exclusion criteria will be asked to
join the study testing the efficacy of twice daily esomeprazole 40 mg taken for 3 months in
the setting of chronic cough. Potential subjects will be consented for the study prior to
leaving the enrolling clinic. A total of 40 subjects will be recruited into our study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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