Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

Study Overview
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Brief Summary
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This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.

Official Title
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A Multicenter, Double -Blind, Placebo-controlled Study to Evaluate the Effects of Esomeprazole 40mg Bid on the Signs and Symptoms of Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

Conditions
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Chronic Posterior Laryngitis (CPL)

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness. Patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria. Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system. Exclusion Criteria: A number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol. If the patient is on certain medications this will also preclude them from taking part.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Esomeprazole<br>* 40mg orally twice daily<br>* Other names: Nexium;|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid |  | Dialy diary cards, investigator assessments, laryngoscopy at week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily diary cards and investigator symptom assessment throughout to evaluate the efficacy of acid suppression therapy on resolution of signs of CPL at weeks 8 and 16 in patients without documented pharyngeal acid reflux. |  | Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16 | 
| Quality of life Questionnaire |  | Quality of life questionnaire completed at screening and week 16 | 
| To evaluate the safety and tolerability by collecting an ongoing record of adverse events. |  | Ongoing to week 16. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nexium, Chronic Posterior Laryngitis, CPL, Pharyngeal acid reflux, Esomeprazole