Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Chronic Posterior Laryngitis (CPL)

Treatments: Drug: Esomeprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628667

D9611C00002

SH-NEE-0002

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Esomeprazole

2

Placebo Comparator group

Treatment:

Drug: Placebo