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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Beclomethasone dipropionate
• Drug: Flunisolide

Primary Measures

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

Secondary 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)

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trial, M.D. Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00346775

Study ID Number: FFR105693

ClinicalTrials.gov Identifier: NCT00346775

Health Authority: United States: Food and Drug Administration