Laryngopharyngeal Reflux
Conditions
Keywords
Gastroesophageal reflux, Laryngitis, Hoarseness, Dysphonia, Proton pump inhibitor
Brief summary
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.
Detailed description
The investigators 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.
Interventions
DRUGLansoprazole
Lansoprazole 30mg twice daily
DIETARY_SUPPLEMENTSugar pill
placebo twice daily
Sponsors
American Institute for Voice and Ear Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improvement or Resolution of Arytenoid Erythema | 6 weeks | Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks |
Countries
United States
Participant flow
Recruitment details
Inadequate recruitment during this study; therefore, the study was terminated.
Participants by arm
| Arm | Count |
|---|---|
| Sugar Pill Placebo for Lansoprazole twice daily | 4 |
| Lansoprazole Lansoprazole 30 mg twice daily | 7 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 4 | 7 |
Baseline characteristics
| Characteristic | Lansoprazole | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age Continuous | 40.1 years STANDARD_DEVIATION 17.33 | 33.0 years STANDARD_DEVIATION 11.56 | 37.5 years STANDARD_DEVIATION 15.83 |
| Region of Enrollment United States | 7 participants | 4 participants | 11 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 |
Outcome results
Primary
Percentage of Participants With Improvement or Resolution of Arytenoid Erythema
Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks
Time frame: 6 weeks
Population: No results to report; Study was terminated