Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis
1 other identifier
interventional
131
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedNovember 2, 2015
October 1, 2015
1 month
June 23, 2011
October 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ)
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).
2 days
Study Arms (5)
epinastine 0.1%
EXPERIMENTALnasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.1% with taste masking agent
EXPERIMENTALnasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.2%
EXPERIMENTALnasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.2% with taste masking agent
EXPERIMENTALnasal spray 2 sprays to each nostril for a total of 3 doses
azelastine 0.1%
ACTIVE COMPARATORnasal spray 2 sprays in each nostril for a total of 3 doses
Interventions
nasal spray 2 sprays to each nostril for a total for a 3 doses
nasal spray 2 sprays to each nostril for a total of 3 doses
Eligibility Criteria
You may qualify if:
- between ages 18-70
- history of SAR or PAR for 1 year
- mild symptoms
You may not qualify if:
- asthma or RAD
- respiratory tract infection within 14 days prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
September 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
November 2, 2015
Record last verified: 2015-10