The Utility of Nexium in Chronic Cough and Reflux Disease

NCT00287339 | Completed Phase 4 Results

• 1 other identifier: AZ COUGH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough; GERD

Keywords

Cough; GERD

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 12 weeks

Study Arms (2)

1

EXPERIMENTAL

40mg Esomeprazole BID

Drug: Esomeprazole

2

PLACEBO COMPARATOR

placebo capsules

Drug: Placebo

Interventions

Esomeprazole DRUG

40mg capsule BID for 12 weeks

Also known as: Brand name is Nexium

1

Placebo DRUG

placebo capsule BID for 12 weeks

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• AstraZeneca: collaborator

Study Sites (1)

UNC Gastroenterology, UNC Pulmonology, UNC ENT

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 21083673 RESULT

MeSH Terms

Conditions

Cough; Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This study was performed at a single center, and participants were mostly female and white, which may limit generalizability. The number of subjects in some patient subgroups was small.

Results Point of Contact

• Title: Dr Nicholas Shaheen
• Organization: UNC_ChapelHill

nshaheen@med.unc.edu

919 9667047

Study Officials

• Nicholas Shaheen, MD, MPH

  UNC Gastroenterology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: February 6, 2006
• Study Start: September 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 10, 2012
• Results First Posted: June 2, 2011

Record last verified: 2012-01

Locations

US (1)