Clinical Trial: Quality of Life Validation in Laryngitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Refl

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 Summary:
Sponsor: AstraZeneca

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety assessments via adverse event recording and physical examinations [ Time Frame: 2 monthly ]

Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: March 18, 2008
Date Started: May 2001
Date Completion:
Last Updated: June 10, 2009
Last Verified: June 2009