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OpenTrials
Completed

NCT Number: NCT01277341

Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Completed

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female at least 12 years of age with a history of mountain cedar allergy

Exclusion criteria

  • No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

Treatment and study plan

Bepotastine Besilate Nasal Spray 2% Twice a day

Drug

nasal spray

Bepotastine Besilate Nasal Spray 3% Twice a day

Drug

nasal spray

Bepotastine Besilate Nasal Spray 4% Twice a day

Drug

nasal spray

Placebo nasal spray

Drug

nasal spray

Primary outcomes

  1. Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS

    Time frame: Baseline, 14 days

    Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 14, 2011
Registry last updated
Oct 5, 2020

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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