The Utility of Nexium in Chronic Cough and Reflux Disease - Full Text View

Sponsors and Collaborators:	The University of North Carolina, Chapel Hill AstraZeneca
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00287339

Purpose

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.

Condition	Intervention	Phase
Cough GERD	Drug: Esomeprazole Drug: Placebo	Phase IV

MedlinePlus related topics: Cough

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Chronic Cough and Reflux Disease: A Randomized, Double-Blinded, Placebo Controlled Trial of High Dose Proton Pump Inhibition

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Differences between the Cough-Specific Quality of Life Questionnaire between active treatment and placebo groups, and,differences in Fisman Cough Frequency/Cough Severity Scores between active treatment and placebo groups. [ Time Frame: Measured at screening and 3 times during treatment ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	September 2005
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 40mg Esomeprazole BID	Drug: Esomeprazole 40mg capsule BID for 12 weeks
2: Placebo Comparator placebo capsules	Drug: Placebo placebo capsule BID for 12 weeks

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287339

Locations

United States, North Carolina
UNC Gastroenterology, UNC Pulmonology, UNC ENT
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

AstraZeneca

Investigators

Principal Investigator:

Nicholas Shaheen, MD, MPH

UNC Gastroenterology

More Information

Responsible Party:	UNC-Chapel Hill ( Nicholas J. Shaheen, MD, MPH )
Study ID Numbers:	AZ COUGH
Study First Received:	February 3, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00287339
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of North Carolina, Chapel Hill:

Cough
GERD

Study placed in the following topic categories:

Signs and Symptoms
Respiratory Tract Diseases
Respiration Disorders

Omeprazole
Signs and Symptoms, Respiratory
Cough

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009