A Phase 4 interventional study of Esomeprazole and Placebo in Cough and GERD, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-10.
Sponsored by University of North Carolina, Chapel Hill · Phase 4, Interventional, and Treatment
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.
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.
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 263 interventional studies indexed under Cough.
Browse Cough studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40mg Esomeprazole BID
Drug: Esomeprazole
placebo capsules
Drug: Placebo
40mg capsule BID for 12 weeks
Also known as: Brand name is Nexium
placebo capsule BID for 12 weeks
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.
Time frame: baseline and 12 weeks
recruited from hospital clinics - subjects with chronic cough.
| Milestone | Esomeprazole Arm | Placebo |
|---|---|---|
| Started | 22 | 18 |
| Completed | 22 | 18 |
| Not completed | 0 | 0 |
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.
| participants | Esomeprazole Arm | Placebo |
|---|---|---|
| Change in Cough-Specific Quality of Life Questionnaire | 9.8 ± 12.2 | 5.8 ± 11.1 |
Collected over 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Esomeprazole Arm | — | 0/22 (0%) | 0/22 (0%) |
| Placebo | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Esomeprazole Arm | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 17 | 37 |
| >=65 years | 2 | 1 | 3 |
| Age Continuous(years) | Esomeprazole Arm | Placebo | Total |
|---|---|---|---|
| Mean | 49.5 ± 12 | 51.0 ± 11.6 | 50 ± 11.7 |
| Sex: Female, Male(Participants) | Esomeprazole Arm | Placebo | Total |
|---|---|---|---|
| Female | 16 | 15 | 31 |
| Male | 6 | 3 | 9 |
| Region of Enrollment(participants) | Esomeprazole Arm | Placebo | Total |
|---|---|---|---|
| United States | 22 | 18 | 40 |
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill