Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis
Phase 2
Completed
- Conditions
- Allergic Rhinitis
- Interventions
- Registration Number
- NCT01382654
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description epinastine 0.1% with taste masking agent epinastine 0.1% with taste masking agent nasal spray 2 sprays to each nostril for a total of 3 doses epinastine 0.2% epinastine 0.2% nasal spray 2 sprays to each nostril for a total of 3 doses azelastine 0.1% azelastine 0.1% nasal spray 2 sprays in each nostril for a total of 3 doses epinastine 0.1% epinastine 0.1% nasal spray 2 sprays to each nostril for a total of 3 doses epinastine 0.2% with taste masking agent epinastine 0.2% with taste masking agent nasal spray 2 sprays to each nostril for a total of 3 doses
- Primary Outcome Measures
Name Time Method Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ) 2 days
- Secondary Outcome Measures
Name Time Method Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine). 2 days