Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Olopatadine Hydrochloride Nasal Spray 0.6%; Olopatadine Hydrochloride Nasal Spray Vehicle
Intervention description: one spray in each nostril twice daily for 2 weeks; one spray in each nostril twice daily for 2 weeks
Intervention MeSH terms: Olopatadine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Allergic Rhinitis; Pediatric; PATANASE

Summary:

      The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine
      Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2
      to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics
      (study of the action of a drug in the body) in these children
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be at least 2 years of age and less than 6 years of age on Day 1;

          -  Parent/legal guardian must be willing and able to give written informed consent and
             must provide this consent for the study;

          -  Patient must have a positive case history of allergic rhinitis symptoms and at least
             one documented positive skin test within the 5 years prior to Day 1 of the following
             type: skin prick test, intradermal test or RAST test(radioallergosorbent test) for an
             allergen (≥ 3 mm wheal greater than diluent after skin prick testing; ≥ 7 mm wheal
             greater than the diluent after intradermal testing; or positive level 2 or greater
             after RAST testing);

          -  Patient and parent/caregiver must be willing and able to make required study visits;

          -  Patient and parent/caregiver must be able to follow instructions;

          -  Nasal exam must confirm absence of significant anatomic abnormalities, infection,
             bleeding, and mucosal ulcerations at Screening and prior to administration of test
             article at the Day 1 Visit. A finding of 'present' for any of these parameters
             disqualifies the patient from the study, regardless of clinical relevance.

        Exclusion Criteria:

          -  The need for chronic or intermittent use of any prescription or over-the-counter nasal
             spray during the study period;

          -  Use of any form of olopatadine (e.g., PATANOL®, PATADAY™, PATANASE®) within 7 days of
             Day 1;

          -  Current or recent (within the last 14 days) use of any drugs/drug classes or
             combinations thereof that may prolong the QT interval;

          -  Patients with a history or evidence of nasolacrimal drainage system malfunction or
             abnormality that may interfere with the results of the study;

          -  Concurrent disease that might complicate or interfere with the investigation or
             evaluation of the study medications (such as rhinitis medicamentosa or large
             obstructive nasal polyps);

          -  Patients with syndromes associated with midfacial deformities or other anatomic nasal
             deformity that may interfere with the patient's participation in the study, as
             identified by physical or nasal examination at Screening or Day 1;

          -  Diagnosis of acute sinusitis within 30 days of Day 1 or diagnosis of chronic
             rhinosinusitis within one year of Day 1;

          -  Congestion that would, in the opinion of the investigator, interfere with successful
             nasal drug administration/absorption (in either nostril);

          -  Upper or lower respiratory infection within 14 days of Day 1;

          -  Asthma, with the exception of intermittent asthma as outlined in Section 18.5, from
             the Stepwise Approach for Managing Asthma in Children 0-4 Years of Age, and Stepwise
             Approach for Managing Asthma in Children 5-11 Years of Age (5);

          -  Current or recent (< 6 months) history of severe, unstable, or uncontrolled
             neurological, cardiovascular, gastrointestinal, hematological, hepatic, and/or renal
             disease, or evidence of other diseases at the physical examination conducted at the
             Screening Visit, which in the opinion of the Investigator would preclude the safe
             participation of the patient in the study;

          -  Hypersensitivity to olopatadine, benzalkonium chloride, or any component of the test
             articles;

          -  History or current infection of HIV (Human Immunodeficiency Virus), hepatitis B or C
             or A, as indicated by the patient's parent or legal guardian response on the
             HIV/Hepatitis survey;

          -  Relatives of study site staff or other individuals who would have access to the
             clinical study protocol;

          -  A family member or any individual residing in the same household of a patient that is
             currently enrolled in the study;

          -  Participation in any other investigational study within 30 days before entry into this
             study (Day 1), or concomitantly with this study;

          -  Clinically relevant abnormal vital signs (pulse rate, average systolic and diastolic
             blood pressure) at Screening or Day 1. The ranges below have been designated as normal
             for the study. Inclusion of patients with values outside of these normal ranges is at
             the discretion of the study investigator;

        Normal Cardiovascular Ranges

          -  Systolic Blood Pressure - 86 to 116 mmHg (millimeters mercury)

          -  Diastolic Blood Pressure -50 to 78 mmHg

          -  Pulse - 75 to 130 bpm (beats per minute)

        In addition, the Alcon Medical Monitor and/or Principal Investigator may declare any
        patient ineligible for the study based upon sound medical reasons.