Quality of Life Validation in Laryngitis

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00641264

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Laryngopharyngeal Reflux (LPR)	Drug: Omeprazole Behavioral: Quality of Life questionnaire	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Laryngopharyngeal Reflux Health Related Quality of Life (LPR-HRQL) Questionnaire Development and Psychometric Testing in Patients Receiving Omeprazole 20 mg Bid as Treatment for Laryngopharyngeal Reflux.

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Jun 1, 2003

Actual Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux [2 monthly]