| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00346775 | Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) | PHASE3 | COMPLETED | 97 | — | — | May 1, 2006 | Jun 29, 2006 | Jan 16, 2018 | 7 | United States |
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.
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).
| Name | Type | Description |
|---|---|---|
| Beclomethasone dipropionate | DRUG | Beclomethasone dipropionate |
| Flunisolide | DRUG | Flunisolide |
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...