The Utility of Nexium in Chronic Cough and Reflux Disease

NCT ID: NCT00287339

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-09-30

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.

Conditions

Cough; GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

40mg Esomeprazole BID

Group Type: EXPERIMENTAL

Esomeprazole

Intervention Type: DRUG

40mg capsule BID for 12 weeks

2

placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo capsule BID for 12 weeks

Interventions

Esomeprazole

40mg capsule BID for 12 weeks

Intervention Type: DRUG

Placebo

placebo capsule BID for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Brand name is Nexium

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Shaheen

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Shaheen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Gastroenterology

Locations

UNC Gastroenterology, UNC Pulmonology, UNC ENT

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21083673 (View on PubMed)

Other Identifiers

AZ COUGH

Identifier Type: -

Identifier Source: org_study_id