Status:
COMPLETED
The Utility of Nexium in Chronic Cough and Reflux Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
AstraZeneca
Conditions:
Cough
GERD
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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...
Detailed Description
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 Sur...
Eligibility Criteria
Inclusion
- 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,
- 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,
- failure to respond to post nasal drip therapy.
Exclusion
- abnormal chest x-ray,
- patients taking H2 blockers within the previous 3 days or PPI's within the previous 7 days,
- failure to respond to past PPI therapy given for cough that lasted at least 12 weeks,
- use of an investigational drug within the past 30 days,
- previous surgical antireflux or non-surgical endoscopic anti-reflux procedure (ex., Stretta or endoscopic sewing device),
- previous aerodigestive malignancy,
- 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),
- upper respiratory infection within 8 weeks prior to study enrollment,
- current use of a B- blocker, ACE-I, or anticholinesterases at time of enrollment.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00287339
Start Date
September 1 2005
End Date
September 1 2008
Last Update
January 10 2012
Active Locations (1)
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1
UNC Gastroenterology, UNC Pulmonology, UNC ENT
Chapel Hill, North Carolina, United States, 27599