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Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01578278
First received: January 18, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes

January 18, 2012
January 3, 2013
December 2011
August 2012   (final data collection date for primary outcome measure)
Change from baseline in 12-hour averaged AM & PM reflective total nasal symptom score [ Time Frame: Day -10 to Day 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01578278 on ClinicalTrials.gov Archive Site
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Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Not Provided

This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in subjects with a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-corticosteroid combination nasal spray, bepotastine besilate nasal spray, corticosteroid nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: Bepotastine besilate formulation
    Nasal Spray
  • Drug: Synthetic corticosteroid
    Nasal Spray
  • Drug: Bepotastine besilate-Synthetic corticosteroid
    Nasal Spray
  • Drug: Placebo Comparator
    Nasal Spray
  • Experimental: Bepotastine besilate formulation
    Nasal Spray
    Intervention: Drug: Bepotastine besilate formulation
  • Experimental: Synthetic corticosteroid
    Nasal Spray
    Intervention: Drug: Synthetic corticosteroid
  • Experimental: Bepotastine besilate-Synthetic corticosteroid
    Nasal Spray
    Intervention: Drug: Bepotastine besilate-Synthetic corticosteroid
  • Placebo Comparator: Placebo Comparator
    Nasal Spray
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
606
Not Provided
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female at least 12 years of age with a demonstrated history of Mountain Cedar pollen allergy

Exclusion Criteria:

  • No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01578278
S00186
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
Bausch & Lomb Incorporated
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP