Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
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ClinicalTrials.gov Identifier: NCT00346775 |
Recruitment Status
:
Completed
First Posted
: June 30, 2006
Results First Posted
: December 6, 2017
Last Update Posted
: January 16, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rhinitis, Allergic, Perennial | Drug: Beclomethasone dipropionate Drug: Flunisolide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 97 participants |
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 |
Actual Study Start Date : | May 1, 2006 |
Actual Primary Completion Date : | June 29, 2006 |
Actual Study Completion Date : | June 29, 2006 |

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Drug: Beclomethasone dipropionate
- 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 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.
- Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores [ Time Frame: Day 1 to Day 23 ]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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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, 95117 | |
GSK Investigational Site | |
San Jose, California, United States, 95128 | |
GSK Investigational Site | |
Walnut Creek, California, United States, 94598 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

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 Posted: | June 30, 2006 Key Record Dates |
Results First Posted: | December 6, 2017 |
Last Update Posted: | January 16, 2018 |
Last Verified: | December 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 |