Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; Placebo nasal spray
Intervention description: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate; 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate; Placebo nasal spray
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 951.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA
      approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Complete the informed consent/assent process.

          2. Male or female between 12 to 65 years of age, inclusive.

          3. Females of childbearing potential willing to use an acceptable form of birth control
             during the study.

          4. Moderate-to-severe allergic rhinitis.

          5. At Visits 1 and 2 have instantaneous and reflective symptom scores sufficient enough
             to qualify for continued participation in the study

          6. Subject must have a history (for 2 or more seasons) of seasonal allergy to at least
             one allergen known to be present during the study season.

          7. Subject must be in general good health with no clinically significant disease or
             medical procedure other than allergic rhinitis within various time periods prior to
             Visit 1.

          8. Subject must be willing and able to understand and comply with the requirements of the
             study

        Exclusion Criteria:

          1. Female who is pregnant or nursing, who is not using or does not agree to use an
             acceptable form of contraception during the study, or who intends to become pregnant
             during the study.

          2. Subject has a history of hypersensitivity or allergy to any ingredient in the drug
             products.

          3. Subject has any condition or abnormality of the upper airway that, in the opinion of
             the Investigator, could interfere with administration of the product, evaluation of
             the subject's condition, or other aspect of the trial.

          4. The presence of any nasal mucosal crusting, erosion, ulceration, nasal septum
             perforation, or any kind of blockage of the nasal passages at screening or
             randomization.

          5. Subject has asthma or a history of asthma requiring chronic treatment within two years
             of Visit 1.

          6. Treatment for oral Candidiasis within 30 days of starting the study, or a current oral
             Candidiasis infection.

          7. Subject has had recent exposure (30 days) or is at risk of being exposed to chicken
             pox or measles.

          8. Subjects with any untreated fungal, bacterial, systemic viral infections within the
             previous 30 days.

          9. Use of various therapies within the given time period prior to Visit 1 and throughout
             the study.

         10. Initiation of hormone replacement therapy during the study.

         11. Initiation of immunotherapy during the study, or changes in dosage or frequency of
             immunotherapy within the 30 days preceding Visit 1.

         12. Subject has received immune-system therapy or peptide immunotherapy of any form.

         13. Subject had desensitization therapy to the seasonal allergen that is causing their
             allergic rhinitis within the previous 6 months.

         14. Subject presented with conjunctivitis or any other eye signs/symptoms that are not
             related to the diagnosis of SAR.

         15. Clinically relevant abnormal physical findings or medication use within 1 week of
             randomization, which, in the opinion of the investigator, might interfere with the
             conduct or results of the study or place the prospective subject at increased risk.

         16. Subjects being treated with a product containing a sympathomimetic agent.

         17. Subject has previously enrolled in this study or is enrolled in this study with
             another participating investigator site.

         18. Subject is concurrently participating in another investigational study or using any
             investigational drug (or biologic) or device.

         19. Subject plans or anticipates travel outside the local allergen area at any point in
             the study.

         20. History of unresponsiveness to steroid nasal sprays for SAR symptoms.

         21. Employee (or employee's family member) of the research center or private practice.

         22. If the subject has a smoking history of greater than 10 pack years or has recently
             started or re-started smoking within the past 2 years