The Utility of Nexium in Chronic Cough and Reflux Disease

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Nicholas Shaheen, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00287339
First received: February 3, 2006
Last updated: January 6, 2012
Last verified: January 2012
  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 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Cough-Specific Quality of Life Questionnaire [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, "I cannot sleep at night" and "I cough and it makes me retch." The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is "strongly disagree," and 4 is "strongly agree." The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment.


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
Experimental: 1
40mg Esomeprazole BID
Drug: Esomeprazole
40mg capsule BID for 12 weeks
Other Name: Brand name is Nexium
Placebo Comparator: 2
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of North Carolina, Chapel Hill
AstraZeneca
Investigators
Principal Investigator: Nicholas Shaheen, MD, MPH UNC Gastroenterology
  More Information

Publications:
Responsible Party: Nicholas Shaheen, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00287339     History of Changes
Other Study ID Numbers: AZ COUGH
Study First Received: February 3, 2006
Results First Received: May 11, 2011
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Cough
GERD

Additional relevant MeSH terms:
Cough
Gastroesophageal Reflux
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014