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

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 Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen attribute rating items followed by fourteen importance weighing questions. The Preference Module includes the same items along with preference questions related to each item as well as a global preference question.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Drug: Beclomethasone dipropionate; Drug: Flunisolide

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • 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
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores	EARNS-Q Preference Module consists of efficacy, sensory perception (SP), device characteristic (DC), spray delivery (SD), overall product preference (OPP) and total domain. TSQM consists of global satisfaction (GS), convenience, effectiveness and side-effects (SE) domains. Positive (+ve) correlation of EARNS-Q preference scores with change on TSQM domains indicate that preference for a product is associated with better TSQM scores. Negative (-ve) correlation with mean daily rTNSS indicate that preference for a product is associated with lower mean daily rTNSS. Change in TSQM domain scores and mean daily rTNSS was calculated as scores in Treatment Period (TP) 2 minus scores in TP1; change in TSQM is +ve, product in TP2 is preferred, vice-versa; change in rTNSS is -ve, product administered in TP2 is preferred, vice-versa.	Day 1 to Day 23
Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores	The 28 items of the EARNS-Q experience module assess 14 attributes with regard to their product rating and their importance of efficacy, SP, DC and SD. The EARNS-Q preference module consists of additional 15 items that evaluate preference by comparing two products based on the same 14 experience attributes as well as on OPP. Change in EARNS-Q Experience Module domain scores was calculated as scores in TP2 minus scores in TP1. If the change in EARNS-Q Experience Module domain scores is +ve, product in TP2 is preferred and vice-versa. A higher product rating for one of the sprays lead to a preference for that spray. The EARNS-Q preference module was assessed only once, at the end of TP2. Positive correlations indicate agreement (i.e. preference for a product is positively associated with better experience with same product).	Day 1 to Day 23

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean rTNSS Over Period	The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a 4 point scale ranging from 0 to 3. Each individual symptom was evaluated using a scale of 0 (none; symptom is not present), 1 (mild; sign/symptom clearly present but minimal awareness; easily tolerated), 2 (moderate; definite awareness of sign/symptom that is bothersome but tolerable), or 3 (severe; sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The rTNSS ranges from 0 (none) to 12 (severe). Higher score represents greater severity of symptoms. The reflective assessment of the TNSS scores the four nasal symptoms over the previous 12 hours and are assessed in the morning and evening. The participants themselves scored nasal symptoms in a diary card. The analysis was done based on the rTNSS averaged over the two weeks of the treatment period.	Day 1 to 8 of each treatment period
Number or Participants With Preference of Nasal Sprays (Nasarel or Beconase AQ) at the End of the Last Cross-over Period Using the Preference Module of the EARNS-Q	The participants with preference of nasal sprays (Nasarel or Beconase AQ) at the end of the last cross-over period was planned to be analyzed using the preference module of the EARNS-Q. The data for this outcome measure was not collected and the result summary was not generated.	Up to Day 23

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2006
• Primary Completion (Actual): June 29, 2006
• Study Completion (Actual): June 29, 2006

Study Registration Dates

• First Submitted: June 28, 2006
• First Submitted That Met QC Criteria: June 28, 2006
• First Posted (Estimate): June 30, 2006

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: allergic rhinitis; questionnaire; nasal spray; Seasonal allergic rhinitis; nasal spray questionnaire
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone; Flunisolide
• Other Study ID Numbers: FFR105693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Annotated Case Report Form
   Information identifier: FFR105693
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: FFR105693
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: FFR105693
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: FFR105693
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: FFR105693
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: FFR105693
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Study Protocol
   Information identifier: FFR105693
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register