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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: epinastine 0.1% with taste masking agent; Drug: azelastine 0.1%; Drug: epinastine 0.2% with taste masking agent; Drug: epinastine 0.2%; Drug: epinastine 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01382654

033-102 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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131 participants in 5 patient groups

epinastine 0.1%

Experimental group

Description:

nasal spray 2 sprays to each nostril for a total of 3 doses

Treatment:

Drug: epinastine 0.1%

epinastine 0.1% with taste masking agent

Experimental group

Description:

nasal spray 2 sprays to each nostril for a total of 3 doses

Treatment:

Drug: epinastine 0.1% with taste masking agent

epinastine 0.2%

Experimental group

Description:

nasal spray 2 sprays to each nostril for a total of 3 doses

Treatment:

Drug: epinastine 0.2%

epinastine 0.2% with taste masking agent

Experimental group

Description:

nasal spray 2 sprays to each nostril for a total of 3 doses

Treatment:

Drug: epinastine 0.2% with taste masking agent

azelastine 0.1%

Active Comparator group

Description:

nasal spray 2 sprays in each nostril for a total of 3 doses

Treatment:

Drug: azelastine 0.1%