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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Rhinitis

Intervention: epinastine 0.1% (Drug); epinastine 0.1% with taste masking agent (Drug); epinastine 0.2% (Drug); epinastine 0.2% with taste masking agent (Drug); azelastine 0.1% (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)

Secondary outcome: Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine).


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: September 2006
Last updated: October 8, 2014

Page last updated: August 23, 2015

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