Quality of Life Validation in Laryngitis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laryngopharyngeal Reflux (LPR) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Infections Laryngeal Diseases Laryngitis Laryngopharyngeal Reflux Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole

Drug

Other names: Losec

Quality of Life Questionnaire

Behavioral

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2003
First posted: Mar 24, 2008
Registry last updated: Jun 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed