Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Beclomethasone dipropionate
- Drug: Flunisolide
Outcome Measures for this Clinical Trial
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)
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trial, M.D. Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00346775
