The Utility of Nexium in Chronic Cough and Reflux Disease
Condition: Cough; GERD
MeSH terms: Cough
Intervention: Esomeprazole; Placebo
Intervention description: 40mg capsule BID for 12 weeks; placebo capsule BID for 12 weeks
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cough; GERD

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. males and females (of non-childbearing potential. ie-surgically sterile, or willing to
             use an approved form of birth control) between the ages of 18 and 70 who speak and
             write in English,

          2. chronic cough (> 8 wks/another article used > 6 wks) with symptom severity criteria of
             2 or greater on the Fisman Cough Severity Score and 3 or greater or the Fisman Cough
             Frequency Score, and,

          3. failure to respond to post nasal drip therapy.

        Exclusion Criteria:

          1. abnormal chest x-ray,

          2. patients taking H2 blockers within the previous 3 days or PPI's within the previous 7
             days,

          3. failure to respond to past PPI therapy given for cough that lasted at least 12 weeks,

          4. use of an investigational drug within the past 30 days,

          5. previous surgical antireflux or non-surgical endoscopic anti-reflux procedure (ex.,
             Stretta or endoscopic sewing device),

          6. previous aerodigestive malignancy,

          7. current smokers, or ex-smokers (defined as those who quit smoking less than 3 months
             prior to study enrollment or those who have quit, but have a 20 pack year smoking
             history),

          8. upper respiratory infection within 8 weeks prior to study enrollment,

          9. current use of a B- blocker, ACE-I, or anticholinesterases at time of enrollment.