Quality of Life Validation in Laryngitis

Phase 4

Completed

• Conditions: Laryngopharyngeal Reflux (LPR)

• Registration Number: NCT00641264
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Study First Posted: 2008-03-24
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-10
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Safety assessments via adverse event recording and physical examinations	2 monthly