Clinical trial NCT01307319: Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
Official title: Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
SAR
Keywords: Allergies
Hayfever
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 715
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment
timeFrame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15
Secondary outcomes:
measure: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment
timeFrame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Teva Clinical Study Site
state: Alabama
city: Bell
country: United States
facility: Teva Clinical Study Site
state: California
city: Costa Mesa
country: United States
facility: Teva Clinical Study Site
state: California
city: Mission Viejo
country: United States
facility: Teva Clinical Study Site
state: California
city: Orange
country: United States
facility: Teva Clinical Study Site
state: California
city: Paramount
country: United States
facility: Teva Clinical Study Site
state: California
city: San Diego
country: United States
facility: Teva Clinical Study Site
state: California
city: San Diego
country: United States
facility: Teva Clinical Study Site
state: California
city: Stockton
country: United States
facility: Teva Clinical Study Site
state: California
city: Centennial
country: United States
facility: Teva Clinical Study Site
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Clinical Study Site
state: Colorado
city: Gainesville
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Lawrenceville
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Savannah
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Stockbridge
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Indianapolis
country: United States
facility: Teva Clinical Study Site
state: Indiana
city: Bethesda
country: United States
facility: Teva Clinical Study Site
state: Maryland
city: Minneapolis
country: United States
facility: Teva Clinical Study Site
state: Minnesota
city: Plymouth
country: United States
facility: Teva Clinical Study Site
state: Minnesota
city: Columbia
country: United States
facility: Teva Clinical Study Site
state: Missouri
city: Rolla
country: United States
facility: Teva Clinical Study Site
state: Missouri
city: Warrensburg
country: United States
facility: Teva Clinical Study Site
state: Missouri
city: Bozeman
country: United States
facility: Teva Clinical Study Site
state: Montana
city: Brick
country: United States
facility: Teva Clinical Study Site
state: New Jersey
city: High Point
country: United States
facility: Teva Clinical Study Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Teva Clinical Study Site
state: Oklahoma
city: Portland
country: United States
facility: Teva Clinical Study Site
state: Oregon
city: Blue Bell
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Collegeville
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Charleston
country: United States
facility: Teva Clinical Study Site
state: South Carolina
city: Orangeburg
country: United States
facility: Teva Clinical Study Site
state: South Carolina
city: Austin
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Teva Clinical Study Site
state: Texas
city: El Paso
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Ft. Worth
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Kerrville
country: United States
facility: Teva Clinical Study Site
state: Texas
city: New Braunfels
country: United States
facility: Teva Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Waco
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Burke
country: United States
facility: Teva Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: Teva Clinical Study Site
state: Virginia
Study officials:
References:
citation: Storms WW, Segall N, Mansfield LE, Amar NJ, Kelley L, Ding Y, Tantry SK. Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2013 Nov;111(5):408-414.e1. doi: 10.1016/j.anai.2013.07.033. Epub 2013 Aug 28.