Allergic Rhinitis
Conditions
Brief summary
The objectives of this study were to: * Examine the tolerability of two formulations and two dose concentrations of epinastine. * Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study. * Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.
Interventions
DRUGepinastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
DRUGepinastine 0.1% with taste masking agent
nasal spray 2 sprays to each nostril for a total for a 3 doses
DRUGepinastine 0.2%
nasal spray 2 sprays to each nostril for a total of 3 doses
DRUGepinastine 0.2% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
DRUGazelastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* between ages 18-70 * history of SAR or PAR for 1 year * mild symptoms
Exclusion criteria
* asthma or RAD * respiratory tract infection within 14 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ) | 2 days |
Secondary
| Measure | Time frame |
|---|---|
| Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine). | 2 days |
Outcome results
None listed