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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: 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%

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: epinastine 0.1%; nasal spray 2 sprays to each nostril for a total of 3 doses	Drug: epinastine 0.1%; nasal spray 2 sprays to each nostril for a total of 3 doses
Experimental: epinastine 0.1% with taste masking agent; nasal spray 2 sprays to each nostril for a total of 3 doses	Drug: epinastine 0.1% with taste masking agent; nasal spray 2 sprays to each nostril for a total for a 3 doses
Experimental: epinastine 0.2%; nasal spray 2 sprays to each nostril for a total of 3 doses	Drug: epinastine 0.2%; nasal spray 2 sprays to each nostril for a total of 3 doses
Experimental: epinastine 0.2% with taste masking agent; nasal spray 2 sprays to each nostril for a total of 3 doses	Drug: epinastine 0.2% with taste masking agent; nasal spray 2 sprays to each nostril for a total of 3 doses
Active Comparator: azelastine 0.1%; nasal spray 2 sprays in each nostril for a total of 3 doses	Drug: azelastine 0.1%; nasal spray 2 sprays to each nostril for a total of 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)	2 days

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 8, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Azelastine; Epinastine
• Other Study ID Numbers: 033-102 (Other Identifier: Inspire Pharmaceuticals)