Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

Condition(s) targeted: Laryngopharyngeal Reflux

Intervention: Lansoprazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: American Institute for Voice and Ear Research

Official(s) and/or principal investigator(s):
Robert T Sataloff, MD, DMA, Principal Investigator, Affiliation: American Institute for Voice and Ear Research

Overall contact:
Robert T Sataloff, MD, DMA, Phone: 215-545-3322, Email: RTSataloff@PhillyENT.com

The purpose of this study is to determine whether Lansoprazole 30mg taken twice daily is effective in the treatment of laryngitis due to gastroesophageal reflux.

Official title: A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis

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

Primary outcome: Improvement or resolution of arytenoid erythema; score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks.

Secondary outcome:

Voice quality assessed subjectively and objectively at 6 weeks.

Reflux symptoms assessed by patients' completion of Reflux Symptom Index at 6 weeks.

Quality of life assessed by patient questionnaire at 6 weeks.

Standard objective voice measures performed by member of research staff at 6 weeks.

Safety and efficacy of Lansoprazole on non-acid laryngopharyngeal reflux will be studied in open-labeled, uncontrolled, single group, sub-study of 30 patients using the same primary and secondary outcome measures.

Detailed description: We propose to study the effect of Lansoprazole 30 mg bid therapy vs. placebo in patients who present with symptoms characteristic of reflux laryngitis. The efficacy of Lansoprazole 30 mg bid in healing and improving reflux laryngitis will be determined. For the purpose of this study, healed reflux laryngitis will be defined as an improvement or resolution of arytenoid erythema and improvement in symptoms. Improved reflux laryngitis will be defined as improvement in any two of the following areas: arytenoid erythema; voice quality as assessed by the patients or health care provider; or, improvement/resolution of related symptoms (throat clearing, cough, etc.). The impact of Lansoprazole 30 mg bid therapy on quality of life will be evaluated in a preliminary fashion.

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

Criteria:

Inclusion Criteria:

- Vocal skills necessary to complete test procedures reliably.

- Voice complaints and/or other symptoms suggestive of reflux laryngitis

- Signed informed consent

- At least 18 years of age.

- Complete medical history and physical examination within 30 days prior to initiation

of the study drug.

- Laryngoscopy documenting laryngeal pathology compatible with moderate to severe

reflux laryngitis (> grade 3 arytenoid erythema) within 30 days of initiation of the study drug.

- Gastroesophageal reflux confirmed by 24-hour (a minimum of 16 hours required for

inclusion) pH impedance monitor.

- Ambulatory outpatient status.

- If female, a negative pregnancy test at the screening visit or either: i) surgically

sterilized (bilateral tubal ligation or hysterectomy), or ii) at least 1 year post-menopausal, or iii) using acceptable methods of contraception in the presence of childbearing potential.

Exclusion Criteria:

- Concurrent laryngeal disease, if such disease or its treatment would interfere with

evaluation of study results. For example, patients with mass lesions such as laryngeal cysts or laryngeal carcinoma will be excluded. Patients with acute laryngeal infections or acute laryngeal allergies will be excluded until these conditions have been resolved; but they may be considered for inclusion thereafter.

- Any upper gastroenterological or esophageal surgery except simple over-sewing of a

perforated ulcer.

- Active substance abuse.

- Tobacco use.

- Known hypersensitivity or allergy to any protein pump inhibitor.

- ALT (SGPT) or AST (SGOT) greater than 2 times the upper limit of normal.

- Renal impairment (serum creatinine > 2. 0 mg/dl).

- Any clinically significant, unstable medical condition.

- Use of any proton pump inhibitor within 7 days prior to 24-hour pH impedance

monitoring or baseline strobovideolaryngoscopy, or use of H2 receptor antagonist during the 48 hours prior to 24-hour pH impedance monitoring or baseline strobovideolaryngoscopy.

- Use of an investigational drug or participation in an investigational study, within

30 days prior to starting study drug.

- Previous participation in this study.

- Pregnant women.

- Women breast feeding infants.

- Inability or refusal to follow directions.

- Open label sub-study has same inclusion and exclusion criteria, with exception that

subjects should have: 1) Clinical diagnosis of non-acid reflux, with less than 5 episodes of proximal acid reflux, and 2) Symptoms and signs consistent with gastroesophageal reflux.

Robert T Sataloff, MD, DMA, Phone: 215-545-3322, Email: RTSataloff@PhillyENT.com

Henry Ford Hospital, Department of Otolaryngology, Detroit, Michigan 48202-2699, United States; Recruiting
Michael Benninger, MD, Phone: 313-916-3275
Tiffany Pierce, Phone: (313) 916-1784
Michael Benninger, MD, Principal Investigator

American Institute for Voice and Ear Research, Philadelphia, Pennsylvania 19103, United States; Recruiting
Robert T Sataloff, MD, DMA, Phone: 215-545-3322, Email: RTSataloff@PhillyENT.com
Cynthia Watson, RN, BSN, Phone: 215-545-3322
Robert T Sataloff, MD, DMA, Principal Investigator

Cornell University, Van Lawrence Voice Center, Houston, Texas 77030, United States; Recruiting
Richard Stasney, MD, Phone: 713-796-2001
Margarita Rodrigez, Phone: 713-796-2001
Richard Stasney, MD, Principal 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. Laryngopharyngeal reflux symptoms improve before changes in physical findings. Laryngoscope. 2001 Jun;111(6):979-81.

Bogdasarian RS, Olson NR. Posterior glottic laryngeal stenosis. Otolaryngol Head Neck Surg. 1980 Nov-Dec;88(6):765-72. No abstract available.

Cherry J, Margulies SI. Contact ulcer of the larynx. Laryngoscope. 1968 Nov;78(11):1937-40. No abstract available.

Delahunty JE, Cherry J. Experimentally produced vocal cord granulomas. Laryngoscope. 1968 Nov;78(11):1941-7. No abstract available.

Eherer AJ, Habermann W, Hammer HF, Kiesler K, Friedrich G, Krejs GJ. Effect of pantoprazole on the course of reflux-associated laryngitis: a placebo-controlled double-blind crossover study. Scand J Gastroenterol. 2003 May;38(5):462-7.

El-Serag HB, Lee P, Buchner A, Inadomi JM, Gavin M, McCarthy DM. Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial. Am J Gastroenterol. 2001 Apr;96(4):979-83.

Koufman J, Sataloff RT, Toohill R. Laryngopharyngeal reflux: consensus conference report. J Voice. 1996 Sep;10(3):215-6. No abstract available.

Morrison MD. Is chronic gastroesophageal reflux a causative factor in glottic carcinoma? Otolaryngol Head Neck Surg. 1988 Oct;99(4):370-3.

Noordzij JP, Khidr A, Evans BA, Desper E, Mittal RK, Reibel JF, Levine PA. Evaluation of omeprazole in the treatment of reflux laryngitis: a prospective, placebo-controlled, randomized, double-blind study. Laryngoscope. 2001 Dec;111(12):2147-51.

Vaezi MF, Richter JE, Stasney CR, Spiegel JR, Iannuzzi RA, Crawley JA, Hwang C, Sostek MB, Shaker R. Treatment of chronic posterior laryngitis with esomeprazole. Laryngoscope. 2006 Feb;116(2):254-60.

Wetmore RF. Effects of acid on the larynx of the maturing rabbit and their possible significance to the sudden infant death syndrome. Laryngoscope. 1993 Nov;103(11 Pt 1):1242-54. Review.

Starting date: August 2006
Ending date: August 2006
Last updated: March 18, 2008