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

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

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).

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Placebo; Drug: BDP Nasal Aerosol

• Study Type: Interventional
• Enrollment (Actual): 547
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States
      • Teva Investigational Site 10522
  • California
    • Costa Mesa, California, United States
      • Teva Investigational Site 10518
    • Downey, California, United States
      • Teva Investigational Site 10526
    • Huntington Beach, California, United States
      • Teva Investigational Site 10496
    • Huntington Beach, California, United States
      • Teva Investigational Site 10536
    • Mission Viejo, California, United States
      • Teva Investigational Site 10479
    • Orange, California, United States
      • Teva Investigational Site 10524
    • Paramount, California, United States
      • Teva Investigational Site 10508
    • San Diego, California, United States
      • Teva Investigational Site 10495
    • San Diego, California, United States
      • Teva Investigational Site 10504
    • Stockton, California, United States
      • Teva Investigational Site 10505
  • Colorado
    • Centennial, Colorado, United States
      • Teva Investigational Site 10514
    • Colorado Springs, Colorado, United States
      • Teva Investigational Site 10503
  • Georgia
    • Lawrenceville, Georgia, United States
      • Teva Investigational Site 10499
    • Savannah, Georgia, United States
      • Teva Investigational Site 10474
    • Stockbridge, Georgia, United States
      • Teva Investigational Site 10490
    • Stockbridge, Georgia, United States
      • Teva Investigational Site 10498
  • Illinois
    • Dekalb, Illinois, United States
      • Teva Investigational Site 10509
    • Normal, Illinois, United States
      • Teva Investigational Site 10493
  • Indiana
    • Indianapolis, Indiana, United States
      • Teva Investigational Site 10486
  • Kentucky
    • Louisville, Kentucky, United States
      • Teva Investigational Site 10494
  • Massachusetts
    • North Dartmouth, Massachusetts, United States
      • Teva Investigational Site 10515
  • Michigan
    • Traverse City, Michigan, United States
      • Teva Investigational Site 10540
  • Missouri
    • Columbia, Missouri, United States
      • Teva Investigational Site 10513
  • Montana
    • Missoula, Montana, United States
      • Teva Investigational Site 10532
  • New Jersey
    • Brick, New Jersey, United States
      • Teva Investigational Site 10507
  • New York
    • Corning, New York, United States
      • Teva Investigational Site 10534
    • Cortland, New York, United States
      • Teva Investigational Site 10492
    • Niagara Falls, New York, United States
      • Teva Investigational Site 10517
    • Rochester, New York, United States
      • Teva Investigational Site 10482
    • Watertown, New York, United States
      • Teva Investigational Site 10535
  • North Carolina
    • High Point, North Carolina, United States
      • Teva Investigational Site 10478
    • Holly Springs, North Carolina, United States
      • Teva Investigational Site 10516
  • Ohio
    • Canton, Ohio, United States
      • Teva Investigational Site 10485
    • Cincinnati, Ohio, United States
      • Teva Investigational Site 10480
    • Cleveland, Ohio, United States
      • Teva Investigational Site 10500
    • Middleburg Heights, Ohio, United States
      • Teva Investigational Site 10529
  • Oregon
    • Ashland, Oregon, United States
      • Teva Investigational Site 10537
    • Medford, Oregon, United States
      • Teva Investigational Site 10527
    • Portland, Oregon, United States
      • Teva Investigational Site 10502
  • Pennsylvania
    • Blue Bell, Pennsylvania, United States
      • Teva Investigational Site 10477
    • Upland, Pennsylvania, United States
      • Teva Investigational Site 10484
  • Rhode Island
    • Warwick, Rhode Island, United States
      • Teva Investigational Site 10511
  • South Carolina
    • Charleston, South Carolina, United States
      • Teva Investigational Site 10497
    • Orangeburg, South Carolina, United States
      • Teva Investigational Site 10521
  • Tennessee
    • Knoxville, Tennessee, United States
      • Teva Investigational Site 10528
  • Texas
    • Boerne, Texas, United States
      • Teva Investigational Site 10483
    • Dallas, Texas, United States
      • Teva Investigational Site 10489
    • Dallas, Texas, United States
      • Teva Investigational Site 10520
    • El Paso, Texas, United States
      • Teva Investigational Site 10476
    • Kerrville, Texas, United States
      • Teva Investigational Site 10491
    • Plano, Texas, United States
      • Teva Investigational Site 10487
    • Plano, Texas, United States
      • Teva Investigational Site 10501
    • San Antonio, Texas, United States
      • Teva Investigational Site 10523
    • San Antonio, Texas, United States
      • Teva Investigational Site 10531
    • San Antonio, Texas, United States
      • Teva Investigational Site 10539
    • Waco, Texas, United States
      • Teva Investigational Site 10475
  • Utah
    • Salt Lake City, Utah, United States
      • Teva Investigational Site 10488
    • Salt Lake City, Utah, United States
      • Teva Investigational Site 10506
    • Salt Lake City, Utah, United States
      • Teva Investigational Site 10510
  • Virginia
    • Burke, Virginia, United States
      • Teva Investigational Site 10519
    • Richmond, Virginia, United States
      • Teva Investigational Site 10481
    • Richmond, Virginia, United States
      • Teva Investigational Site 10533

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BDP Nasal Aerosol 80 mcg/day; 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.	Drug: BDP Nasal Aerosol; Other Names: QNASL®; Beclomethasone dipropionate
Placebo Comparator: Placebo Nasal Aerosol; Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6
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	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.	Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6
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	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.	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: allergic rhinitis; pediatric subjects; BDP nasal aerosol
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: BDP-AR-306