Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Perennial
Intervention: Beclomethasone dipropionate (Drug); Flunisolide (Drug)
Phase: Phase 3
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
The objective of this cross-over study is to validate the Preference Module of the EARNS-Q
in adult subjects (>=18 years of age) with Seasonal Allergic Rhinitis (SAR) taking
beclomethasone dipropionate and beclomethasone dipropionate and flunisolide.
Official title: A Randomized, Single-Blind, Cross-Over, Multicenter Study to Validate the Preference Module of the Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Administered to Adult Subjects With Seasonal Allergic Rhinitis During a Three-week Cross-over Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: No primary efficacy endpoint - this study concerns the validation of EARNS-Q.
Patient preference with nasal sprays
mean rTNSS (reflective total nasal symptom scores) over the 2-week treatment period
correlation with other measures of preference using TSQM (Treatment Satisfaction Questionnaire for Medication)
Minimum age: 18 Years.
Maximum age: N/A.
- Seasonal allergic rhinitis.
- Nasal allergy symptoms during the spring allergy season.
- Prior use of beclomethasone dipropionate or flunisolide.
- Significant concomitant medical conditions.
- Use of corticosteroids.
- Use of allergy and other identified medications during the study.
- Current tobacco use or tobacco use within the past year.
Locations and Contacts
GSK Investigational Site, Fresno, California 93720, United States
GSK Investigational Site, Napa, California 94558, United States
GSK Investigational Site, Roseville, California 95678, United States
GSK Investigational Site, San Francisco, California 94102, United States
GSK Investigational Site, San Jose, California 95117, United States
GSK Investigational Site, San Jose, California 95128, United States
GSK Investigational Site, Walnut Creek, California 94598, United States
Starting date: May 2006
Last updated: February 13, 2014