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

This study has been completed.

First Received: June 28, 2006 Last Updated: August 17, 2006 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Flunisolide Beclomethasone Beclomethasone dipropionate

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)

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

No publications provided

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

Keywords provided by GlaxoSmithKline:

Seasonal allergic rhinitis
allergic rhinitis
nasal spray questionnaire
nasal spray
questionnaire

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Beclomethasone
Rhinitis
Hormones
Glucocorticoids

Pharmacologic Actions
Nose Diseases
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Flunisolide
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009