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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00794144
First received: November 17, 2008
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
Drug: Olopatadine Hydrochloride Nasal Spray Vehicle
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Number of Participants With Anatomic Nasal Exam Abnormalities [ Time Frame: Day 1 (Baseline) to Exit ] [ Designated as safety issue: Yes ]
    The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa


Enrollment: 132
Study Start Date: October 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Olopatadine Hydrochloride Nasal Spray 0.6%
Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
one spray in each nostril twice daily for 2 weeks
Placebo Comparator: 2
Olopatadine Hydrochloride Nasal Spray Vehicle
Drug: Olopatadine Hydrochloride Nasal Spray Vehicle
one spray in each nostril twice daily for 2 weeks

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794144

Locations
United States, Texas
Niran Amar, M.D.
Waco, Texas, United States, 76712
Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Niran Amar, MD
Principal Investigator: Sheri Byrd, MD Spartanburg Medical Center
Principal Investigator: Albert Finn, MD National Allergy, Asthma, & Urticaria
Principal Investigator: Joseph Flanagan, MD Health Sciences Research Center
Principal Investigator: Brad H Goodman, MD Aeroallergy Research Laboratories
Principal Investigator: Frank Hampel, MD Central Texas Allergy and Asthma
Principal Investigator: Yu-Luen Hsu, MD West Coast Clinical Trials Phase 2-4
Principal Investigator: Neil Kao, MD Allergic Disease and Asthma Cente
Principal Investigator: John Prestigiacomo, MD Gulf Coast Research Associates, Inc
Principal Investigator: Paul Ratner, MD Sylvana Research Associates
Principal Investigator: Christopher Smith, MD Asthma and Allergy Associates, P.C.
  More Information

No publications provided

Responsible Party: Cynthia M. Rusk\Manager, Development, Alcon Research
ClinicalTrials.gov Identifier: NCT00794144     History of Changes
Other Study ID Numbers: C-07-02
Study First Received: November 17, 2008
Results First Received: January 12, 2010
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Allergic Rhinitis
Pediatric
PATANASE

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Olopatadine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014