Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) - Full Text View

Purpose

This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Bepotastine besilate Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Dose-Ranging Study to Evaluate the Safety and Efficacy of Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) in Subjects With a Demonstrated History of Mountain Cedar Pollen Allergic Sensitivity

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Bepotastine

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

Nasal Symptoms Score [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Improvement from baseline in averaged AM and PM values for reflective total nasal symptom score (rTNSS). Nasal symptoms rated on a 4 point (0-3 units) scale where 0=none and 3=severe.

Secondary Outcome Measures:

Nasal Symptom Score by day [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Improvement from baseline in averaged AM and PM values for reflective total nasal symptom score (rTNSS) by day. Nasal symptoms rated on a 4 point (0-3 units) scale where 0=none and 3=severe.
Nasal and Ocular Symptom Score [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Improvement from baseline for additional total and individual nasal and ocular symptom scores other than rTNSS.
50% reduction in Nasal Symptom Score [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Proportion of subjects that achieve a 50% reduction in rTNSS from baseline

Other Outcome Measures:

Total and Individual Mean domain scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S])

Estimated Enrollment:	600
Study Start Date:	January 2013
Estimated Study Completion Date:	May 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bepotastine besilate Concentration 1 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Active Comparator: Placebo Placebo nasal spray BID for 14 days	Drug: Placebo Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Experimental: Bepotastine besilate Concentration 2 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Experimental: Bepotastine besilate Concentration 3 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Experimental: Bepotastine besilate Concentration 4 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject is a male or female 12 years of age or older.
Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1.
Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test.
Have a minimum rTNSS of at least 6 units for the AM assessment on the day of Visit 2 and Visit 3.
Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
Have a minimum stuffy nose score of at least 2 units on the day of Visit 3.
Have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
Have at least one score ≥ 2 units at Visit 3 of any of the RQLQ(S) questions #4-#6 regarding sleep.

Exclusion Criteria:

Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit 2.
Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist.
Is participating or have participated in any investigational drug or device study within 30 days preceding Visit 2.
Have had nasal or sinus surgery within 12 weeks of Visit 2.
Have a known sensitivity to bepotastine besilate or any excipient component of the IP.
For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753739

Locations

United States, California
Bausch & Lomb Incorporated
Irvine, California, United States, 92618-2301

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

Study Director:

Jon Williams, Ph.D.

Bausch & Lomb Incorporated

More Information

No publications provided

Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT01753739 History of Changes
Other Study ID Numbers:	823
Study First Received:	December 18, 2012
Last Updated:	February 19, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity

Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 21, 2013