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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

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

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.

Secondary outcome:

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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Seasonal allergic rhinitis.

- Nasal allergy symptoms during the spring allergy season.

Exclusion Criteria:

- 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

Additional Information

Starting date: May 2006
Last updated: February 13, 2014

Page last updated: August 23, 2015

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