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

NCT00794144 | Completed Phase 2 Results

• 1 other identifier: C-07-02
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis; Pediatric; PATANASE

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Anatomic Nasal Exam Abnormalities

  The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa

  Day 1 (Baseline) to Exit

Study Arms (2)

1

EXPERIMENTAL

Olopatadine Hydrochloride Nasal Spray 0.6%

Drug: Olopatadine Hydrochloride Nasal Spray 0.6%

2

PLACEBO COMPARATOR

Olopatadine Hydrochloride Nasal Spray Vehicle

Drug: Olopatadine Hydrochloride Nasal Spray Vehicle

Interventions

Olopatadine Hydrochloride Nasal Spray 0.6% DRUG

one spray in each nostril twice daily for 2 weeks

1

Olopatadine Hydrochloride Nasal Spray Vehicle DRUG

one spray in each nostril twice daily for 2 weeks

2

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Niran Amar, M.D.

Waco, Texas, 76712, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Research Ltd

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: March 4, 2010
• Results First Posted: February 4, 2010

Record last verified: 2010-02

Locations

US (1)