Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

AstraZeneca120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Chronic Posterior Laryngitis (CPL)

Interventions

EsomeprazoleDRUG

40mg orally twice daily

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Dialy diary cards, investigator assessments, laryngoscopy at week 16

Secondary Outcomes

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.

Time frame: Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16

Quality of life Questionnaire

Time frame: Quality of life questionnaire completed at screening and week 16

To evaluate the safety and tolerability by collecting an ongoing record of adverse events.

Time frame: Ongoing to week 16.

Data from ClinicalTrials.gov

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