Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Beclomethasone

Criteria

Inclusion Criteria:

• Informed Consent

• Documented history of perennial allergic rhinitis

• A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.

• Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)

• Other criteria apply

Exclusion Criteria:

• History of physical findings of nasal pathology (within 60 days prior to screening visit)

• Participation in any investigational drug study 30 days preceding screening visit

• History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period

• Use of any prohibited concomitant medications