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

Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382654
• Other study ID #: 033-102
• Secondary ID: 033-102
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2011
• Last updated: October 8, 2015
• Start date: September 2006
• Est. completion date: October 2006

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• epinastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
• epinastine 0.1% with taste masking agent
nasal spray 2 sprays to each nostril for a total for a 3 doses
• epinastine 0.2%
nasal spray 2 sprays to each nostril for a total of 3 doses
• epinastine 0.2% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
• azelastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)		2 days	No
Secondary	Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine).		2 days	No