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

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

epinastine 0.1%

epinastine 0.1% with taste masking agent

epinastine 0.2%

epinastine 0.2% with taste masking agent

azelastine 0.1%

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

epinastine 0.1%

epinastine 0.1% with taste masking agent

epinastine 0.2%

epinastine 0.2% with taste masking agent

azelastine 0.1%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01382654

First Posted

June 23, 2011

Last Updated

October 8, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01382654

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

epinastine 0.1%

Arm Type

Experimental

Arm Description

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

Arm Title

epinastine 0.1% with taste masking agent

Arm Type

Experimental

Arm Description

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

Arm Title

epinastine 0.2%

Arm Type

Experimental

Arm Description

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

Arm Title

epinastine 0.2% with taste masking agent

Arm Type

Experimental

Arm Description

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

Arm Title

azelastine 0.1%

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

epinastine 0.1%

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

epinastine 0.1% with taste masking agent

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

epinastine 0.2%

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

epinastine 0.2% with taste masking agent

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

azelastine 0.1%

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 days

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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