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

NCT01783548 | Completed Phase 3 Results

• 1 other identifier: BDP-AR-306
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 63

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).

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; pediatric subjects; BDP nasal aerosol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

BDP Nasal Aerosol 80 mcg/day

EXPERIMENTAL

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

Placebo Nasal Aerosol

PLACEBO COMPARATOR

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

Interventions

BDP Nasal Aerosol DRUG

Also known as: Beclomethasone dipropionate, QNASL®

BDP Nasal Aerosol 80 mcg/day

Placebo DRUG

Placebo Nasal Aerosol

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

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

Study Sites (63)

Teva Investigational Site 10522

Hot Springs, Arkansas, United States

Location

Teva Investigational Site 10518

Costa Mesa, California, United States

Location

Teva Investigational Site 10526

Downey, California, United States

Location

Teva Investigational Site 10496

Huntington Beach, California, United States

Location

Teva Investigational Site 10536

Huntington Beach, California, United States

Location

Teva Investigational Site 10479

Mission Viejo, California, United States

Location

Teva Investigational Site 10524

Orange, California, United States

Location

Teva Investigational Site 10508

Paramount, California, United States

Location

Teva Investigational Site 10495

San Diego, California, United States

Location

Teva Investigational Site 10504

San Diego, California, United States

Location

Teva Investigational Site 10505

Stockton, California, United States

Location

Teva Investigational Site 10514

Centennial, Colorado, United States

Location

Teva Investigational Site 10503

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 10499

Lawrenceville, Georgia, United States

Location

Teva Investigational Site 10474

Savannah, Georgia, United States

Location

Teva Investigational Site 10490

Stockbridge, Georgia, United States

Location

Teva Investigational Site 10498

Stockbridge, Georgia, United States

Location

Teva Investigational Site 10509

DeKalb, Illinois, United States

Location

Teva Investigational Site 10493

Normal, Illinois, United States

Location

Teva Investigational Site 10486

Indianapolis, Indiana, United States

Location

Teva Investigational Site 10494

Louisville, Kentucky, United States

Location

Teva Investigational Site 10515

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10540

Traverse City, Michigan, United States

Location

Teva Investigational Site 10513

Columbia, Missouri, United States

Location

Teva Investigational Site 10532

Missoula, Montana, United States

Location

Teva Investigational Site 10507

Brick, New Jersey, United States

Location

Teva Investigational Site 10534

Corning, New York, United States

Location

Teva Investigational Site 10492

Cortland, New York, United States

Location

Teva Investigational Site 10517

Niagara Falls, New York, United States

Location

Teva Investigational Site 10482

Rochester, New York, United States

Location

Teva Investigational Site 10535

Watertown, New York, United States

Location

Teva Investigational Site 10478

High Point, North Carolina, United States

Location

Teva Investigational Site 10516

Holly Springs, North Carolina, United States

Location

Teva Investigational Site 10485

Canton, Ohio, United States

Location

Teva Investigational Site 10480

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10500

Cleveland, Ohio, United States

Location

Teva Investigational Site 10529

Middleburg Heights, Ohio, United States

Location

Teva Investigational Site 10537

Ashland, Oregon, United States

Location

Teva Investigational Site 10527

Medford, Oregon, United States

Location

Teva Investigational Site 10502

Portland, Oregon, United States

Location

Teva Investigational Site 10477

Blue Bell, Pennsylvania, United States

Location

Teva Investigational Site 10484

Upland, Pennsylvania, United States

Location

Teva Investigational Site 10511

Warwick, Rhode Island, United States

Location

Teva Investigational Site 10497

Charleston, South Carolina, United States

Location

Teva Investigational Site 10521

Orangeburg, South Carolina, United States

Location

Teva Investigational Site 10528

Knoxville, Tennessee, United States

Location

Teva Investigational Site 10483

Boerne, Texas, United States

Location

Teva Investigational Site 10489

Dallas, Texas, United States

Location

Teva Investigational Site 10520

Dallas, Texas, United States

Location

Teva Investigational Site 10476

El Paso, Texas, United States

Location

Teva Investigational Site 10491

Kerrville, Texas, United States

Location

Teva Investigational Site 10487

Plano, Texas, United States

Location

Teva Investigational Site 10501

Plano, Texas, United States

Location

Teva Investigational Site 10523

San Antonio, Texas, United States

Location

Teva Investigational Site 10531

San Antonio, Texas, United States

Location

Teva Investigational Site 10539

San Antonio, Texas, United States

Location

Teva Investigational Site 10475

Waco, Texas, United States

Location

Teva Investigational Site 10488

Salt Lake City, Utah, United States

Location

Teva Investigational Site 10506

Salt Lake City, Utah, United States

Location

Teva Investigational Site 10510

Salt Lake City, Utah, United States

Location

Teva Investigational Site 10519

Burke, Virginia, United States

Location

Teva Investigational Site 10481

Richmond, Virginia, United States

Location

Teva Investigational Site 10533

Richmond, Virginia, United States

Location

Related Publications (1)

• 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.

  PMID: 26115578 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

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: January 31, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 12, 2015
• Results First Posted: October 12, 2015

Record last verified: 2015-09

Locations

US (63)