Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis, SAR

In brief

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

Key facts

Study ID: NCT01307319
Run by: Teva Branded Pharmaceutical Products R&D, Inc.
People needed: 715
Starts: 2011-03-01
Expected to finish: 2011-08-01
Last updated by the study team: 2015-02-20

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)
A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR through a standard skin prick test.
Other criteria apply

You may not qualify if…

History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit [SV])
History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable
Have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial
Other criteria apply

Where it is running

Teva Clinical Study Site — Oxford, Alabama, United States
Teva Clinical Study Site — Bell, California, United States
Teva Clinical Study Site — Costa Mesa, California, United States
Teva Clinical Study Site — Mission Viejo, California, United States
Teva Clinical Study Site — Orange, California, United States
Teva Clinical Study Site — Paramount, California, United States
Teva Clinical Study Site — San Diego, California, United States
Teva Clinical Study Site — San Diego, California, United States
Teva Clinical Study Site — Stockton, California, United States
Teva Clinical Study Site — Centennial, Colorado, United States
Teva Clinical Study Site — Colorado Springs, Colorado, United States
Teva Clinical Study Site — Gainesville, Georgia, United States
Teva Clinical Study Site — Lawrenceville, Georgia, United States
Teva Clinical Study Site — Savannah, Georgia, United States
Teva Clinical Study Site — Stockbridge, Georgia, United States
Teva Clinical Study Site — Indianapolis, Indiana, United States
Teva Clinical Study Site — Bethesda, Maryland, United States
Teva Clinical Study Site — Minneapolis, Minnesota, United States
Teva Clinical Study Site — Plymouth, Minnesota, United States
Teva Clinical Study Site — Columbia, Missouri, United States
Teva Clinical Study Site — Rolla, Missouri, United States
Teva Clinical Study Site — Warrensburg, Missouri, United States
Teva Clinical Study Site — Bozeman, Montana, United States
Teva Clinical Study Site — Brick, New Jersey, United States
Teva Clinical Study Site — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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