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
  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:


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:
    Drug: Beclomethasone dipropionate
    Beclomethasone dipropionate
    Drug: Flunisolide
    Flunisolide
    Other Names:
    • Flunisolide
    • Beclomethasone dipropionate
  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 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, 95128
GSK Investigational Site
San Jose, California, United States, 95117
GSK Investigational Site
Walnut Creek, California, United States, 94598
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on April 22, 2014