Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Azelastine; Epinastine

Criteria

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