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

NCT01382654 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2015-11-02

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

epinastine 0.1%

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

DRUG

epinastine 0.2%

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

DRUG

azelastine 0.1%

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2006-10-31
Completion
2006-10-31

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382654 on ClinicalTrials.gov