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Completed

NCT Number: NCT01382654

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epinastine 0.1%

Drug

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

epinastine 0.1% with taste masking agent

Drug

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

epinastine 0.2%

Drug

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

epinastine 0.2% with taste masking agent

Drug

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

azelastine 0.1%

Drug

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

Primary outcomes

  1. Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)

    Time frame: 2 days

Secondary outcomes

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

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 27, 2011
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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