Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01753739
First received: December 18, 2012
Last updated: July 30, 2014
Last verified: May 2014
  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:


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])


Enrollment: 613
Study Start Date: January 2013
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 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 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 investigational product (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 29, 2014