Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
1 other identifier
interventional
715
1 country
45
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
February 20, 2015
CompletedFebruary 20, 2015
February 1, 2015
4 months
February 28, 2011
February 3, 2015
February 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15
Secondary Outcomes (1)
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
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15
Study Arms (3)
BDP HFA 80 mcg/day
EXPERIMENTALParticipants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
BDP HFA 160 mcg/day
EXPERIMENTALParticipants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
Placebo nasal aerosol once daily
PLACEBO COMPARATORParticipants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Interventions
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Teva Clinical Study Site
Oxford, Alabama, 36203, United States
Teva Clinical Study Site
Bell, California, 90201, United States
Teva Clinical Study Site
Costa Mesa, California, 92626, United States
Teva Clinical Study Site
Mission Viejo, California, 92691, United States
Teva Clinical Study Site
Orange, California, 92868, United States
Teva Clinical Study Site
Paramount, California, 90723, United States
Teva Clinical Study Site
San Diego, California, 92120, United States
Teva Clinical Study Site
San Diego, California, 92123, United States
Teva Clinical Study Site
Stockton, California, 95207, United States
Teva Clinical Study Site
Centennial, Colorado, 80112, United States
Teva Clinical Study Site
Colorado Springs, Colorado, 80907, United States
Teva Clinical Study Site
Gainesville, Georgia, 30501, United States
Teva Clinical Study Site
Lawrenceville, Georgia, 30046, United States
Teva Clinical Study Site
Savannah, Georgia, 31406, United States
Teva Clinical Study Site
Stockbridge, Georgia, 30281, United States
Teva Clinical Study Site
Indianapolis, Indiana, 43208, United States
Teva Clinical Study Site
Bethesda, Maryland, 20814, United States
Teva Clinical Study Site
Minneapolis, Minnesota, 55402, United States
Teva Clinical Study Site
Plymouth, Minnesota, 55441, United States
Teva Clinical Study Site
Columbia, Missouri, 65203, United States
Teva Clinical Study Site
Rolla, Missouri, 65401, United States
Teva Clinical Study Site
Warrensburg, Missouri, 64093, United States
Teva Clinical Study Site
Bozeman, Montana, 597158, United States
Teva Clinical Study Site
Brick, New Jersey, 08724, United States
Teva Clinical Study Site
High Point, North Carolina, 27262, United States
Teva Clinical Study Site
Oklahoma City, Oklahoma, 73102, United States
Teva Clinical Study Site
Portland, Oregon, 97213, United States
Teva Clinical Study Site
Blue Bell, Pennsylvania, 19422, United States
Teva Clinical Study Site
Collegeville, Pennsylvania, 19426, United States
Teva Clinical Study Site
Philadelphia, Pennsylvania, 19115, United States
Teva Clinical Study Site
Pittsburgh, Pennsylvania, 15241, United States
Teva Clinical Study Site
Charleston, South Carolina, 20460, United States
Teva Clinical Study Site
Orangeburg, South Carolina, 29119, United States
Teva Clinical Study Site
Austin, Texas, 78731, United States
Teva Clinical Study Site
Dallas, Texas, 75230, United States
Teva Clinical Study Site
Dallas, Texas, 75246, United States
Teva Clinical Study Site
El Paso, Texas, 79903, United States
Teva Clinical Study Site
Fort Worth, Texas, 76132, United States
Teva Clinical Study Site
Houston, Texas, 77054, United States
Teva Clinical Study Site
Kerrville, Texas, 78028, United States
Teva Clinical Study Site
New Braunfels, Texas, 78130, United States
Teva Clinical Study Site
San Antonio, Texas, 78229, United States
Teva Clinical Study Site
Waco, Texas, 76712, United States
Teva Clinical Study Site
Burke, Virginia, 22015, United States
Teva Clinical Study Site
Richmond, Virginia, 23233, United States
Related Publications (1)
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.
PMID: 24125150DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 2, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
February 20, 2015
Results First Posted
February 20, 2015
Record last verified: 2015-02