Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)
NCT ID: NCT01753739
Last Updated: 2020-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
617 participants
INTERVENTIONAL
2013-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bepotastine besilate Concentration 1
Bepotastine besilate nasal spray, BID for 14 days.
Bepotastine besilate
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Placebo
Placebo nasal spray BID for 14 days
Placebo
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Bepotastine besilate Concentration 2
Bepotastine besilate nasal spray, BID for 14 days.
Bepotastine besilate
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Bepotastine besilate Concentration 3
Bepotastine besilate nasal spray, BID for 14 days.
Bepotastine besilate
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Bepotastine besilate Concentration 4
Bepotastine besilate nasal spray, BID for 14 days.
Bepotastine besilate
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Interventions
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Bepotastine besilate
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Placebo
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Eligibility Criteria
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Inclusion Criteria
* 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 morning (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 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 investigational product (IP).
12 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jon Williams, Ph.D.
Role: STUDY_DIRECTOR
Bausch & Lomb Incorporated
Locations
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Bausch & Lomb Incorporated
Irvine, California, United States
Countries
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Other Identifiers
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823
Identifier Type: -
Identifier Source: org_study_id
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