Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)

Completed · Phase 3 · Has a placebo group

Conditions studied: Allergic Rhinitis

In brief

The purpose of this study is to evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).

Key facts

Study ID

NCT01783548

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

547

Starts

2013-01-01

Expected to finish

2013-10-01

Last updated by the study team

2015-10-12

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects 4 to 11 years of age, inclusive, as of the Screening Visit (SV).
• A documented history of PAR to a relevant perennial allergen for a minimum of 12 months (6 months for subjects 4 to 5 years of age) immediately preceding the study Screening Visit (SV).
• A demonstrated sensitivity to at least one allergen known to induce PAR 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 of the following 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 Investigational Site 10518 — Costa Mesa, California, United States
• Teva Investigational Site 10526 — Downey, California, United States
• Teva Investigational Site 10496 — Huntington Beach, California, United States
• Teva Investigational Site 10536 — Huntington Beach, California, United States
• Teva Investigational Site 10479 — Mission Viejo, California, United States
• Teva Investigational Site 10524 — Orange, California, United States
• Teva Investigational Site 10508 — Paramount, California, United States
• Teva Investigational Site 10495 — San Diego, California, United States
• Teva Investigational Site 10504 — San Diego, California, United States
• Teva Investigational Site 10505 — Stockton, California, United States
• Teva Investigational Site 10514 — Centennial, Colorado, United States
• Teva Investigational Site 10503 — Colorado Springs, Colorado, United States
• Teva Investigational Site 10499 — Lawrenceville, Georgia, United States
• Teva Investigational Site 10474 — Savannah, Georgia, United States
• Teva Investigational Site 10490 — Stockbridge, Georgia, United States
• Teva Investigational Site 10498 — Stockbridge, Georgia, United States
• Teva Investigational Site 10509 — DeKalb, Illinois, United States
• Teva Investigational Site 10493 — Normal, Illinois, United States
• Teva Investigational Site 10486 — Indianapolis, Indiana, United States
• Teva Investigational Site 10494 — Louisville, Kentucky, United States
• Teva Investigational Site 10515 — North Dartmouth, Massachusetts, United States
• Teva Investigational Site 10540 — Traverse City, Michigan, United States
• Teva Investigational Site 10513 — Columbia, Missouri, United States
• Teva Investigational Site 10532 — Missoula, Montana, United States
• Teva Investigational Site 10522 — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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