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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00346775

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
Seasonal Allergic Rhinitis	Drug: Beclomethasone dipropionate Drug: Flunisolide	Phase IV

MedlinePlus related topics: Hay Fever

Drug Information available for: Beclomethasone dipropionate Beclomethasone Flunisolide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
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

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)

Estimated Enrollment:	90
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Locations

United States, California
GSK Clinical Trials Call Center
Fresno, California, United States, 93720
GSK Clinical Trials Call Center
San Jose, California, United States, 95128
GSK Clinical Trials Call Center
San Jose, California, United States, 95128
GSK Clinical Trials Call Center
Walnut Creek, California, United States, 94598
GSK Clinical Trials Call Center
San Francisco, California, United States, 94104
GSK Clinical Trials Call Center
San Francisco, California, United States, 94102
GSK Clinical Trials Call Center
Roseville, California, United States, 95678
GSK Clinical Trials Call Center
San Jose, California, United States, 95117
GSK Clinical Trials Call Center
Fresno, California, United States, 93720

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, M.D.

GlaxoSmithKline

More Information

Study ID Numbers:	FFR105693
Study First Received:	June 28, 2006
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00346775
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Seasonal allergic rhinitis
allergic rhinitis
nasal spray questionnaire
nasal spray
questionnaire

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Beclomethasone
Flunisolide
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009