Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age

Condition(s) targeted: Allergic Rhinitis

Intervention: Olopatadine Hydrochloride Nasal Spray 0.6% (Drug); Olopatadine Hydrochloride Nasal Spray Vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Niran Amar, MD, Principal Investigator
Sheri Byrd, MD, Principal Investigator, Affiliation: Spartanburg Medical Center
Albert Finn, MD, Principal Investigator, Affiliation: National Allergy, Asthma, & Urticaria
Joseph Flanagan, MD, Principal Investigator, Affiliation: Health Sciences Research Center
Brad H Goodman, MD, Principal Investigator, Affiliation: Aeroallergy Research Laboratories
Frank Hampel, MD, Principal Investigator, Affiliation: Central Texas Allergy and Asthma
Yu-Luen Hsu, MD, Principal Investigator, Affiliation: West Coast Clinical Trials Phase 2-4
Neil Kao, MD, Principal Investigator, Affiliation: Allergic Disease and Asthma Cente
John Prestigiacomo, MD, Principal Investigator, Affiliation: Gulf Coast Research Associates, Inc
Paul Ratner, MD, Principal Investigator, Affiliation: Sylvana Research Associates
Christopher Smith, MD, Principal Investigator, Affiliation: Asthma and Allergy Associates, P.C.

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Number of Participants With Anatomic Nasal Exam Abnormalities

Minimum age: 2 Years. Maximum age: 5 Years. Gender(s): Both.

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.

Niran Amar, M.D., Waco, Texas 76712, United States

Starting date: October 2008
Last updated: February 23, 2010