Clinical trial NCT01783548: Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week, Clinical Study Designed to Assess the Efficacy and Safety of BDP Nasal Aerosol (80 mcg, Once Daily) in Pediatric Subjects (4 to 11 Years of Age) With PAR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis
pediatric subjects
BDP nasal aerosol
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 547
Sex: ALL
Minimum age (years): 4
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 evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).


Eligibility criteria: Inclusion Criteria:

* 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.

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 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.

Primary outcomes:
measure: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age
timeFrame: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6
Secondary outcomes:
measure: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age
timeFrame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6
measure: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age
timeFrame: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6
measure: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age
timeFrame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Teva Investigational Site 10522
state: Arkansas
city: Costa Mesa
country: United States
facility: Teva Investigational Site 10518
state: California
city: Downey
country: United States
facility: Teva Investigational Site 10526
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10496
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10536
state: California
city: Mission Viejo
country: United States
facility: Teva Investigational Site 10479
state: California
city: Orange
country: United States
facility: Teva Investigational Site 10524
state: California
city: Paramount
country: United States
facility: Teva Investigational Site 10508
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10495
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10504
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 10505
state: California
city: Centennial
country: United States
facility: Teva Investigational Site 10514
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 10503
state: Colorado
city: Lawrenceville
country: United States
facility: Teva Investigational Site 10499
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 10474
state: Georgia
city: Stockbridge
country: United States
facility: Teva Investigational Site 10490
state: Georgia
city: Stockbridge
country: United States
facility: Teva Investigational Site 10498
state: Georgia
city: Dekalb
country: United States
facility: Teva Investigational Site 10509
state: Illinois
city: Normal
country: United States
facility: Teva Investigational Site 10493
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 10486
state: Indiana
city: Louisville
country: United States
facility: Teva Investigational Site 10494
state: Kentucky
city: North Dartmouth
country: United States
facility: Teva Investigational Site 10515
state: Massachusetts
city: Traverse City
country: United States
facility: Teva Investigational Site 10540
state: Michigan
city: Columbia
country: United States
facility: Teva Investigational Site 10513
state: Missouri
city: Missoula
country: United States
facility: Teva Investigational Site 10532
state: Montana
city: Brick
country: United States
facility: Teva Investigational Site 10507
state: New Jersey
city: Corning
country: United States
facility: Teva Investigational Site 10534
state: New York
city: Cortland
country: United States
facility: Teva Investigational Site 10492
state: New York
city: Niagara Falls
country: United States
facility: Teva Investigational Site 10517
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site 10482
state: New York
city: Watertown
country: United States
facility: Teva Investigational Site 10535
state: New York
city: High Point
country: United States
facility: Teva Investigational Site 10478
state: North Carolina
city: Holly Springs
country: United States
facility: Teva Investigational Site 10516
state: North Carolina
city: Canton
country: United States
facility: Teva Investigational Site 10485
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 10480
state: Ohio
city: Cleveland
country: United States
facility: Teva Investigational Site 10500
state: Ohio
city: Middleburg Heights
country: United States
facility: Teva Investigational Site 10529
state: Ohio
city: Ashland
country: United States
facility: Teva Investigational Site 10537
state: Oregon
city: Medford
country: United States
facility: Teva Investigational Site 10527
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 10502
state: Oregon
city: Blue Bell
country: United States
facility: Teva Investigational Site 10477
state: Pennsylvania
city: Upland
country: United States
facility: Teva Investigational Site 10484
state: Pennsylvania
city: Warwick
country: United States
facility: Teva Investigational Site 10511
state: Rhode Island
city: Charleston
country: United States
facility: Teva Investigational Site 10497
state: South Carolina
city: Orangeburg
country: United States
facility: Teva Investigational Site 10521
state: South Carolina
city: Knoxville
country: United States
facility: Teva Investigational Site 10528
state: Tennessee
city: Boerne
country: United States
facility: Teva Investigational Site 10483
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10489
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10520
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 10476
state: Texas
city: Kerrville
country: United States
facility: Teva Investigational Site 10491
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 10487
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 10501
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10523
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10531
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10539
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 10475
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 10488
state: Utah
city: Salt Lake City
country: United States
facility: Teva Investigational Site 10506
state: Utah
city: Salt Lake City
country: United States
facility: Teva Investigational Site 10510
state: Utah
city: Burke
country: United States
facility: Teva Investigational Site 10519
state: Virginia
city: Richmond
country: United States
facility: Teva Investigational Site 10481
state: Virginia
city: Richmond
country: United States
facility: Teva Investigational Site 10533
state: Virginia
Study officials:
References:
citation: Berger WE, Jacobs RL, Amar NJ, Tantry SK, Li J, Small CJ. Efficacy and safety of beclomethasone dipropionate nasal aerosol in children with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Aug;115(2):130-6. doi: 10.1016/j.anai.2015.05.012. Epub 2015 Jun 24.