Quality of Life Validation in Laryngitis

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Laryngopharyngeal Reflux (LPR)

Treatments: Drug: Omeprazole; Behavioral: Quality of Life questionnaire

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641264

294

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)