Intervention: Azelastine/fluticasone propionate
Trial phase: Phase 3
SMILES: CCC(=O)OC1(C(=O)SCF)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C.CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 193
Group description: azelastine HCl/fluticasone propionate
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:

Sleep disturbance
Impairment of daily activities, leisure and/or sport
Impairment of school or work
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