A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Placebo; azelastineHcl; fluticasone propionate; azelastine Hcl/fluticasone propionate
Intervention description: Placebo; azelastine hydrochloride 548 mg; fluticasone propionate 200 mcg; azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1791.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the combination of two allergy medications
      (formulated azelastine/fluticasone product)is more effective than placebo or either component
      medication alone (azelastine or fluticasone).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male/female subjects 12 years of age and older

          2. Provide written informed consent/pediatric assent.

          3. Subjects must have moderate-to-severe rhinitis, with one or more of the following
             present:

               1. Sleep disturbance

               2. Impairment of daily activities, leisure and/or sport

               3. Impairment of school or work

               4. Troublesome symptoms

          4. Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and
             a congestion score of 2 or 3 on Visit 1

          5. Randomization Visit: For the 3 days prior to Randomization and on the morning of
             Randomization, the sum of the 7 consecutive reflective AM and PM TNSS assessments
             shall be equal to or greater than 56, with a nasal congestion score equal to or
             greater than 14

          6. Randomization Visit: instantaneous TNSS score of at least 8 and a congestion score of
             at least 2 just prior to beginning the onset of action assessment

          7. Have taken at least 10 doses of the lead-in medication

          8. Willing and able to comply with the study requirements

          9. At least a 2-year history of SAR during the current allergy season

         10. The presence of IgE-mediated hypersensitivity to a prevailing, individual, seasonal
             pollen, confirmed by a positive response to skin prick within the last year.

         11. General good health and free of any disease or concomitant treatment that could
             interfere with the interpretation of the study results.

         12. Subjects receiving immunotherapy injections (antigen desensitization) must be on a
             stable maintenance regimen for at least 30 days before the first study visit

         13. Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout
             period is required following the last dose of sublingual immunotherapy.

        Exclusion Criteria:

          1. On Focused Nasal Examination, the presence of any superficial and moderate nasal
             mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b - 4)
             at either the screening visit or randomization visit will disqualify the subject from
             the study.

          2. Other nasal disease(s) likely to affect deposition of intranasal medication.

          3. Nasal surgery or sinus surgery within the previous year.

          4. Chronic sinusitis - more than 3 episodes per year

          5. Planned travel outside of the pollen area during the study period

          6. The use of any investigational drug within 30 days prior to Visit 1. No
             investigational products are permitted for use during the conduct of this study

          7. Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or
             fluticasone propionate

          8. Women who are pregnant or nursing

          9. Women of childbearing potential who are not abstinent or not practicing a medically
             acceptable method of contraception* see section 6.1.1

         10. Respiratory Tract Infections within 14 days prior to Visit 1

         11. Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Visit 1

         12. Asthma (with the exception of intermittent asthma).

         13. Significant pulmonary disease including COPD

         14. Clinically significant arrhythmia or symptomatic cardiac conditions

         15. A known history of alcohol or drug abuse within the last 2 years

         16. Existence of any surgical or medical condition or physical or laboratory findings,
             might significantly alter the absorption, distribution, metabolism, or excretion of
             study drug; that might significantly affect the subject's ability to complete this
             trial; or their safety in this trial.

         17. Patients with a history of glaucoma

         18. Clinically relevant abnormal physical findings within 1 week of randomization may
             preclude compliance with the study procedures

         19. Employees of the research center or private practice and their family members

         20. no more than 50% of their subjects have participated in protocol MP4001, MP4002 or
             MP4004