A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

This is an interventional treatment trial for Seasonal Allergic Rhinitis Read More

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