Clinical trial NCT01368445 (phase 3, status: completed)
Conditions: seasonal allergic rhinitis
ICD codes: J30.2
Drugs: azelastine hydrochloride 0.15% nasal spray, azelastine hydrochloride 0.15% and placebo, azelastine 0.1%, nasal spray
SMILES: CN1CCCC(CC1)N1N=C(CC2=CC=C(Cl)C=C2)C2=CC=CC=C2C1=O, CN1CCCC(CC1)N1N=C(CC2=CC=C(Cl)C=C2)C2=CC=CC=C2C1=O, CN1CCCC(CC1)N1N=C(CC2=CC=C(Cl)C=C2)C2=CC=CC=C2C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 12 years of age and older

          -  Provide written informed consent/pediatric assent. If the patient is a minor, a parent
             or legal guardian must give written informed consent

          -  Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at
             least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7

          -  Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM
             or PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day
             1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM
             or PM nasal congestion score of 2 or 3 must have been recorded on 3 separate
             assessments (one of which was within 2 days of Day 1, and can include the morning of
             Day 1).

          -  Must have taken at least 10 doses of study medication during the lead-in period

          -  Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of
             action assessment on Day 1

          -  Willing and able to comply with the study requirements

          -  At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen
             allergy season

          -  The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a
             positive response to either skin prick or intradermal testing within the last year. A
             positive response is defined as a wheal diameter of at least 3 mm larger than the
             control for the skin prick test or at least 7 mm larger than the control for the
             intradermal test.

          -  General good health and free of any disease or concomitant treatment that could
             interfere with the interpretation of the study results as determined by the
             investigator or the sponsor's medical officer

          -  Patients receiving immunotherapy injections (antigen desensitization) must be on a
             stable maintenance regimen for at least 30 days before the first study visit
             (adjustments to regimen following a brief period of missed injections does not
             preclude participation). Patients who are on maintenance doses of sublingual
             immunotherapy may be considered for the trial on a case-by-case basis after discussion
             with the sponsor's medical monitor or designee.

        Exclusion Criteria:

          -  The use of any investigational drug within 30 days prior to Day -7. No investigational
             products are permitted for use during the conduct of this study

          -  Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol
             or sucralose (Splenda® brand sweetener)

          -  Women who are pregnant or nursing

          -  Women of childbearing potential who are not abstinent and not practicing a medically
             acceptable method of contraception

          -  Respiratory tract infections within two weeks prior to Day -7

          -  Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7

          -  Other nasal disease(s) likely to affect deposition of intranasal medication, such as
             sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal
             structural abnormalities

          -  Patients with asthma (with the exception of mild, intermittent asthma)

          -  Patients with significant pulmonary disease

          -  Patients with a known history of alcohol or drug abuse

          -  Existence of any surgical or medical condition, which in the opinion of the
             investigator or sponsor, might significantly alter the absorption, distribution,
             metabolism, or excretion of study drug

          -  Clinically relevant abnormal physical findings within 1 week of randomization which,
             in the opinion of the investigator, would interfere with the objectives of the study
             or that may preclude compliance with the study procedures

          -  Planned travel outside the study area during the study period

          -  Family members and employees should be excluded

          -  Patients who received prohibited medications within specified timepoints in the
             protocol.