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

Phase 3

Completed

Conditions: Allergic Rhinitis

Interventions: Drug: BDP Nasal Aerosol
Drug: Placebo

Registration Number: NCT01783548

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 547

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BDP Nasal Aerosol 80 mcg/day	BDP Nasal Aerosol	BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
Placebo Nasal Aerosol	Placebo	Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.

Primary Outcome Measures

Name	Time	Method
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	Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6	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 and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period.

Secondary Outcome Measures

Name	Time	Method
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	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6	Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes 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 and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period.
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	Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6	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 and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period.
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	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6	Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes 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 and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period.

Trial Locations

Locations (63): Teva Investigational Site 10518
🇺🇸
Costa Mesa, California, United States
Teva Investigational Site 10486
🇺🇸
Indianapolis, Indiana, United States
Teva Investigational Site 10504
🇺🇸
San Diego, California, United States
Teva Investigational Site 10522
🇺🇸
Hot Springs, Arkansas, United States
Teva Investigational Site 10540
🇺🇸
Traverse City, Michigan, United States
Teva Investigational Site 10507
🇺🇸
Brick, New Jersey, United States
Teva Investigational Site 10532
🇺🇸
Missoula, Montana, United States
Teva Investigational Site 10485
🇺🇸
Canton, Ohio, United States
Teva Investigational Site 10500
🇺🇸
Cleveland, Ohio, United States
Teva Investigational Site 10521
🇺🇸
Orangeburg, South Carolina, United States
Teva Investigational Site 10488
🇺🇸
Salt Lake City, Utah, 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 10505
🇺🇸
Stockton, California, 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 10494
🇺🇸
Louisville, Kentucky, United States
Teva Investigational Site 10513
🇺🇸
Columbia, Missouri, United States
Teva Investigational Site 10534
🇺🇸
Corning, New York, United States
Teva Investigational Site 10492
🇺🇸
Cortland, New York, United States
Teva Investigational Site 10517
🇺🇸
Niagara Falls, New York, United States
Teva Investigational Site 10482
🇺🇸
Rochester, New York, United States
Teva Investigational Site 10535
🇺🇸
Watertown, New York, United States
Teva Investigational Site 10478
🇺🇸
High Point, North Carolina, United States
Teva Investigational Site 10516
🇺🇸
Holly Springs, North Carolina, United States
Teva Investigational Site 10480
🇺🇸
Cincinnati, Ohio, United States
Teva Investigational Site 10529
🇺🇸
Middleburg Heights, Ohio, United States
Teva Investigational Site 10477
🇺🇸
Blue Bell, Pennsylvania, United States
Teva Investigational Site 10484
🇺🇸
Upland, Pennsylvania, United States
Teva Investigational Site 10489
🇺🇸
Dallas, Texas, United States
Teva Investigational Site 10511
🇺🇸
Warwick, Rhode Island, United States
Teva Investigational Site 10483
🇺🇸
Boerne, Texas, United States
Teva Investigational Site 10520
🇺🇸
Dallas, Texas, United States
Teva Investigational Site 10476
🇺🇸
El Paso, Texas, United States
Teva Investigational Site 10491
🇺🇸
Kerrville, Texas, United States
Teva Investigational Site 10487
🇺🇸
Plano, Texas, United States
Teva Investigational Site 10523
🇺🇸
San Antonio, Texas, United States
Teva Investigational Site 10501
🇺🇸
Plano, Texas, United States
Teva Investigational Site 10531
🇺🇸
San Antonio, Texas, United States
Teva Investigational Site 10539
🇺🇸
San Antonio, Texas, United States
Teva Investigational Site 10475
🇺🇸
Waco, Texas, United States
Teva Investigational Site 10519
🇺🇸
Burke, Virginia, United States
Teva Investigational Site 10481
🇺🇸
Richmond, Virginia, United States
Teva Investigational Site 10533
🇺🇸
Richmond, Virginia, United States
Teva Investigational Site 10503
🇺🇸
Colorado Springs, Colorado, United States
Teva Investigational Site 10514
🇺🇸
Centennial, Colorado, United States
Teva Investigational Site 10515
🇺🇸
North Dartmouth, Massachusetts, United States
Teva Investigational Site 10528
🇺🇸
Knoxville, Tennessee, United States
Teva Investigational Site 10537
🇺🇸
Ashland, Oregon, United States
Teva Investigational Site 10497
🇺🇸
Charleston, South Carolina, United States
Teva Investigational Site 10506
🇺🇸
Salt Lake City, Utah, United States
Teva Investigational Site 10502
🇺🇸
Portland, Oregon, United States
Teva Investigational Site 10510
🇺🇸
Salt Lake City, Utah, United States
Teva Investigational Site 10527
🇺🇸
Medford, Oregon, United States