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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346775
First Posted: June 30, 2006
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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:
  • 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 [ Time Frame: Day 1 to Day 23 ]
    EARNS-Q consist 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. rTNSS score is sum of individual symptom scores for rhinorrhea, nasal congestion, itching, and sneezing, scored in scale ranging from 0-3, total score range from 0 (none) to 12 (severe). 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.

  • Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores [ Time Frame: Day 1 to Day 23 ]
    EARNS-Q consist of efficacy, SP, DC, SD, OPP and total domains. 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. Positive correlations indicate agreement (i.e. preference for a product is positively associated with better experience with same product).


Secondary Outcome Measures:
  • Mean rTNSS Over Period [ Time Frame: Day 1 to 8 of each treatment 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.

  • 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 [ Time Frame: Up to Day 23 ]
    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.


Enrollment: 97
Study Start Date: May 1, 2006
Study Completion Date: June 29, 2006
Primary Completion Date: June 1, 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Beclomethasone dipropionate
    Beclomethasone dipropionate
    Drug: Flunisolide
    Flunisolide
    Other Name: Beclomethasone dipropionate
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346775


Locations
United States, California
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Frisco, California, United States, 94102
GSK Investigational Site
Napa, California, United States, 94558
GSK Investigational Site
Roseville, California, United States, 95678
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFR105693
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR105693
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR105693
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR105693
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFR105693
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFR105693
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR105693
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00346775     History of Changes
Other Study ID Numbers: FFR105693
First Submitted: June 28, 2006
First Posted: June 30, 2006
Results First Submitted: June 8, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://

Keywords provided by GlaxoSmithKline:
questionnaire
nasal spray
Seasonal allergic rhinitis
nasal spray questionnaire
allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Flunisolide
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents