Quality of Life Validation in Laryngitis

AstraZeneca90 enrolled

Overview

The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Laryngopharyngeal Reflux (LPR)

Interventions

OmeprazoleDRUG

Quality of Life questionnaireBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment Exclusion Criteria: * Unable to comply with study requirements.

Outcomes

Primary Outcomes

LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux

Time frame: 2 monthly

Secondary Outcomes

Safety assessments via adverse event recording and physical examinations

Time frame: 2 monthly

Data from ClinicalTrials.gov

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