Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rhinitis, Allergic, Perennial	Drug: Beclomethasone dipropionate Drug: Flunisolide	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Flunisolide Beclomethasone dipropionate Beclomethasone dipropionate monohydrate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

No primary efficacy endpoint - this study concerns the validation of EARNS-Q.

Secondary Outcome Measures:

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)


Enrollment:	97
Study Start Date:	May 2006
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Beclomethasone dipropionate

Flunisolide

Other Name: Beclomethasone dipropionate

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00346775

Locations


United States, California
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Napa, California, United States, 94558
GSK Investigational Site
Roseville, California, United States, 95678
GSK Investigational Site
San Francisco, California, United States, 94102
GSK Investigational Site
San Jose, California, United States, 95117
GSK Investigational Site
San Jose, California, United States, 95128
GSK Investigational Site
Walnut Creek, California, United States, 94598

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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