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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Beclomethasone dipropionate
* Drug: Flunisolide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Beclomethasone dipropionate|Beclomethasone dipropionate|
|Drug: Flunisolide|Flunisolide|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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questionnaire, nasal spray, Seasonal allergic rhinitis, nasal spray questionnaire, allergic rhinitis