A Study Evaluating 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: azelastine HCl/fluticasone propionate; azelastine Hcl; fluticasone propionate; placebo
Intervention description: azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID; azelastine Hcl 548 mcg one spray per nostril BID; fluticasone propionate 200 mcg one spray per nostril BID; placebo one spray per nostril BID
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: 776.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if two allergy medications (formulated azelastine
      and fluticasone product) are more effective than placebo or either medication alone
      (azelastine or fluticasone)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 12 years of age and older

          -  Provide written informed consent/pediatric assent. If the subject is a minor, parent
             or legal guardian must give written informed consent

          -  Subjects must have moderate-to-severe rhinitis, defined as having one or more of the
             following:

               1. Sleep disturbance

               2. Impairment of daily activities, leisure and/or sport

               3. Impairment of school or work

               4. Troublesome symptoms

          -  Screening Visit: Have a 12-hour reflective TNSS of at least 8 of 12 and a congestion
             score of 2 or 3 on Visit 1

          -  Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3
             separate symptom assessments (one of which was within 2 days of Day 1, and can include
             the morning of Day 1) during the Lead-in Period.

          -  Randomization Visit: Have an AM or PM 12-hour reflective nasal congestion score of 2
             or 3 must have been recorded on 3 separate symptom assessments (one of which was
             within 2 days of Day 1, and can include the morning of Day 1) Randomization Visit:
             Have an instantaneous TNSS score of 8 or more at time point zero, just prior to
             beginning the onset of action assessment

          -  Have taken at least 10 doses of the lead-in medication

          -  Willing and able to comply with the study requirementsAt least a 2-year history of SAR
             during Fall allergy season

          -  The presence of IgE-mediated hypersensitivity to a local Fall pollen, confirmed by a
             positive response to skin prick within the last year. A positive response is defined
             as a wheal diameter of at least 3 mm larger than the negative control.

          -  General good health and free of disease or concomitant treatment that could interfere
             with the interpretation of the study results

          -  Subjects receiving immunotherapy injections (antigen desensitization) must be on a
             stable maintenance regimen for at least 30 days before the first study visit

          -  Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout
             period is required following the last dose of sublingual immunotherapy.

        Exclusion Criteria:

          -  On Focused Nasal Examination, the presence of any superficial and moderate nasal
             mucosal erosion, nasal mucosal ulceration, or nasal septum perforation at either the
             screening visit or randomization visit

          -  Other nasal disease(s) likely to affect deposition of intranasal medication

          -  Nasal surgery or sinus surgery within the previous year.

          -  Chronic sinusitis - more than 3 episodes per year

          -  Planned travel outside of the pollen area during the study period

          -  The use of any investigational drug within 30 days prior to Day -7.

          -  Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or
             fluticasone propionate

          -  Women who are pregnant or nursing

          -  Women of childbearing potential who are not abstinent or not practicing a medically
             acceptable method of contraception*

          -  Respiratory Tract Infections within 14 days prior to Day -7

          -  Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Day -7

          -  Asthma (with the exception of intermittent asthma).

          -  Significant pulmonary disease including COPD

          -  Clinically significant arrhythmia or symptomatic cardiac conditions

          -  A known history of alcohol or drug abuse within the last 2 years

          -  Existence of any surgical or medical condition or physical or laboratory findings that
             could interfere with study result interpretation.

          -  Patients with a history of Glaucoma

          -  Clinically relevant abnormal physical findings within 1 week of randomization that may
             preclude compliance with the study procedures

          -  Employees of the research center or private practice and their family members are
             excluded

          -  Subjects who participated in protocol MP4001 or MP4002