Prevacid vs Lifestyle Modifications for the Treatment of LPR

Condition(s) targeted: Laryngopharyngeal Reflux

Intervention: Prevacid 30mg BID (Drug); Lifestyle changes of exercise and diet changes for weight loss and avoidance of reflux inducing foods. (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Hodge, Kenneth M., M.D.

Official(s) and/or principal investigator(s):
Kenneth M Hodge, MD, Principal Investigator, Affiliation: Commonwealth Ear, Nose & Throat

Overall contact:
Marti Gardner, MSN, Phone: 502-893-0159, Ext: 1185, Email: mgardner@commonwealthent.com

The purpose of this study is to evaluate changes in scores on the Reflux Finding Score and Reflux Symptom Index over a 24 week period. To enroll subjects must score at least a 13 on the Reflux Symptom Index and at least a 5 on the Reflux Finding Score. All subjects will receive education on lifestyle modifications with a nutritionist and exercise trainer. All subjects will be expected to comply with lifestyle modifications for the entire study period of 24 weeks. Half of all subjects will receive Prevacid 30mg BID and half will receive placebo BID for 24 weeks. Subjects will have 4 office visits over 24 weeks and weekly contacts with the study staff to assess Reflux Symptom Index and any health or medication changes.

Official title: A Comparison of Prevacid 30mg BID Plus Lifestyle Modifications Versus Lifestyle Modifications Alone for the Treatment of Laryngopharyngeal Reflux (LPR) in Adults

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: To compare the numbers of subjects with a Reflux Symptom Index score of less than 13 at visit 3

Secondary outcome: To evaluate the changes in Reflux Finding Score and Reflux Symptom Index from initial scores at screening to final assessment at visit 3.

Detailed description: The results of studies evaluating PPI therapy versus lifestyle modifications for the treatment of LPR have not been conclusive. However, many of these studies were conducted at tertiary care centers. We will look at patients presenting with LPR symptoms in a community setting. All subjects will have an exam of their larynx via laryngoscopy at each of the 4 study visits (screening, week 6, week 12, and week 24). Based on exam findings, the physician will complete the Reflux Finding Score. The subjects will also complete the Reflux Symptom Index weekly to assess for changes in their symptoms. The statistical analysis of this study will include evaluating changes in the Reflux Finding Scores and Reflux Symptom Index scores over the 24 weeks of study participation.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Symptoms of LPR for at least one month, Score of 5 or greater on Reflux Finding Score, Score of 13 or greater on Reflux Symptom Index, and Willing to follow lifestyle modifications.

Exclusion Criteria:

Currently taking PPI twice daily for the treatment of LPR, Women who are pregnant or lactating, History of duodenal or gastric ulcer in the past 5 years, erosive esophagitis, or esophageal obstruction, History of any hypersecretory condition, History of Barrett's esophagus, History of hematemesis in the past 6 months, Currently taking ketoconazole, digoxin, Iron, ampicillin, theophylline, warfarin, or sucralfate, or Suspected disease of the larynx not related to LPR.

Marti Gardner, MSN, Phone: 502-893-0159, Ext: 1185, Email: mgardner@commonwealthent.com

Commonwealth Ear, Nose & Throat, Louisville, Kentucky 40207, United States; Recruiting
Marti Gardner, MSN, Phone: 502-893-0159, Ext: 1185, Email: mgardner@commonwealthent.com
Kenneth M Hodge, MD, Principal Investigator
John R Morris, MD, Sub-Investigator
Donald V Welsh, MD, Sub-Investigator
Gorden T McMurry, MD, Sub-Investigator
Andrew R Gould, MD, Sub-Investigator
Keith D Forwith, PhD, MD, Sub-Investigator
Steven D Shotts, MD, Sub-Investigator
Tamalynn O'Daniel, MSN, ARNP, Sub-Investigator
Jolene H Boswell, PA-C, Sub-Investigator
Mary S McLaughlin, PA-C, Sub-Investigator
Martha L Gardner, MSN, ARNP, Sub-Investigator
Brian Walker, PA-C, Sub-Investigator

Related publications:

Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7.

Belafsky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001 Aug;111(8):1313-7.

Belafsky PC, Postma GN, Amin MR, Koufman JA. Symptoms and findings of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):10-3. Review.

Cohen JT, Bach KK, Postma GN, Koufman JA. Clinical manifestations of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):19-23. Review.

Koufman JA. Laryngopharyngeal reflux 2002: a new paradigm of airway disease. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):2-6. Review.

Koufman JA. Laryngopharyngeal reflux is different from classic gastroesophageal reflux disease. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):7-9. Review.

Postma GN, Belafsky PC, Aviv JE, Koufman JA. Laryngopharyngeal reflux testing. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):14-8. Review.

Postma GN, Johnson LF, Koufman JA. Treatment of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):24-6. Review.

Starting date: December 2005
Ending date: June 2008
Last updated: June 22, 2007