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The Utility of Nexium in Chronic Cough and Reflux Disease

Primary Purpose

Cough, GERD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring Cough, GERD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UNC Gastroenterology, UNC Pulmonology, UNC ENT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

40mg Esomeprazole BID

placebo capsules

Outcomes

Primary Outcome Measures

Change in Cough-Specific Quality of Life Questionnaire
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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2006
Last Updated
January 6, 2012
Sponsor
University of North Carolina, Chapel Hill
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00287339
Brief Title
The Utility of Nexium in Chronic Cough and Reflux Disease
Official Title
Chronic Cough and Reflux Disease: A Randomized, Double-Blinded, Placebo Controlled Trial of High Dose Proton Pump Inhibition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, GERD
Keywords
Cough, GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
40mg Esomeprazole BID
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo capsules
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Brand name is Nexium
Intervention Description
40mg capsule BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsule BID for 12 weeks
Primary Outcome Measure Information:
Title
Change in Cough-Specific Quality of Life Questionnaire
Description
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.
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Shaheen, MD, MPH
Organizational Affiliation
UNC Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Gastroenterology, UNC Pulmonology, UNC ENT
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21083673
Citation
Shaheen NJ, Crockett SD, Bright SD, Madanick RD, Buckmire R, Couch M, Dellon ES, Galanko JA, Sharpless G, Morgan DR, Spacek MB, Heidt-Davis P, Henke D. Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(2):225-34. doi: 10.1111/j.1365-2036.2010.04511.x. Epub 2010 Nov 17.
Results Reference
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The Utility of Nexium in Chronic Cough and Reflux Disease

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