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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00346775

First received: June 28, 2006

Last updated: February 13, 2014

Last verified: February 2014

History of Changes

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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:

MedlinePlus related topics: Hay Fever

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)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00346775 History of Changes
Other Study ID Numbers:	FFR105693
Study First Received:	June 28, 2006
Last Updated:	February 13, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


questionnaire nasal spray Seasonal allergic rhinitis nasal spray questionnaire allergic rhinitis

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity	Immune System Diseases Flunisolide Beclomethasone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents

ClinicalTrials.gov processed this record on September 29, 2016

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