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

Tracking Information

First Received Date ^ICMJE

June 28, 2006

Last Updated Date

August 17, 2006

Start Date ^ICMJE

March 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00346775 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Patient preference with nasal sprays
Mean rTNSS over the 2-week treatment period
Correlation with other measures of preference using TSQM

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Seasonal Allergic Rhinitis

Intervention ^ICMJE

Drug: Beclomethasone dipropionate
Drug: Flunisolide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00346775

Responsible Party

Study ID Numbers ^ICMJE

FFR105693

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, M.D.

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP