Phase 3
Completed N=97
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
Rhinitis, Allergic, Perennial
Source: ClinicalTrials.gov NCT00346775 ↗
Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: 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 — 0.45; 0.45; 0.44; 0.36 correlation coefficient
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.45; 0.45; 0.44; 0.36; -0.39; 0.56 | — |
| PRIMARY Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores |
0.72; 0.38; 0.66; 0.42; 0.38; 0.47 | — |
| SECONDARY Mean rTNSS Over Period |
5.3; 5.1 | 0.517 |
| SECONDARY 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 |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00346775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.