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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BDP Nasal Aerosol
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring allergic rhinitis, pediatric subjects, BDP nasal aerosol

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teva Investigational Site 10522
  • Teva Investigational Site 10518
  • Teva Investigational Site 10526
  • Teva Investigational Site 10496
  • Teva Investigational Site 10536
  • Teva Investigational Site 10479
  • Teva Investigational Site 10524
  • Teva Investigational Site 10508
  • Teva Investigational Site 10495
  • Teva Investigational Site 10504
  • Teva Investigational Site 10505
  • Teva Investigational Site 10514
  • Teva Investigational Site 10503
  • Teva Investigational Site 10499
  • Teva Investigational Site 10474
  • Teva Investigational Site 10490
  • Teva Investigational Site 10498
  • Teva Investigational Site 10509
  • Teva Investigational Site 10493
  • Teva Investigational Site 10486
  • Teva Investigational Site 10494
  • Teva Investigational Site 10515
  • Teva Investigational Site 10540
  • Teva Investigational Site 10513
  • Teva Investigational Site 10532
  • Teva Investigational Site 10507
  • Teva Investigational Site 10534
  • Teva Investigational Site 10492
  • Teva Investigational Site 10517
  • Teva Investigational Site 10482
  • Teva Investigational Site 10535
  • Teva Investigational Site 10478
  • Teva Investigational Site 10516
  • Teva Investigational Site 10485
  • Teva Investigational Site 10480
  • Teva Investigational Site 10500
  • Teva Investigational Site 10529
  • Teva Investigational Site 10537
  • Teva Investigational Site 10527
  • Teva Investigational Site 10502
  • Teva Investigational Site 10477
  • Teva Investigational Site 10484
  • Teva Investigational Site 10511
  • Teva Investigational Site 10497
  • Teva Investigational Site 10521
  • Teva Investigational Site 10528
  • Teva Investigational Site 10483
  • Teva Investigational Site 10489
  • Teva Investigational Site 10520
  • Teva Investigational Site 10476
  • Teva Investigational Site 10491
  • Teva Investigational Site 10487
  • Teva Investigational Site 10501
  • Teva Investigational Site 10523
  • Teva Investigational Site 10531
  • Teva Investigational Site 10539
  • Teva Investigational Site 10475
  • Teva Investigational Site 10488
  • Teva Investigational Site 10506
  • Teva Investigational Site 10510
  • Teva Investigational Site 10519
  • Teva Investigational Site 10481
  • Teva Investigational Site 10533

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BDP Nasal Aerosol 80 mcg/day

Placebo Nasal Aerosol

Arm Description

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: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 31, 2013
Last Updated
September 11, 2015
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01783548
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
allergic rhinitis, pediatric subjects, BDP nasal aerosol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BDP Nasal Aerosol 80 mcg/day
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Nasal Aerosol
Arm Type
Placebo Comparator
Arm Description
Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Intervention Type
Drug
Intervention Name(s)
BDP Nasal Aerosol
Other Intervention Name(s)
Beclomethasone dipropionate, QNASL®
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6
Title
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
Description
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.
Time Frame
Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6
Title
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
Description
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.
Time Frame
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Teva Investigational Site 10522
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Teva Investigational Site 10518
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10526
City
Downey
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10496
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10536
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10479
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10524
City
Orange
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10508
City
Paramount
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10495
City
San Diego
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10504
City
San Diego
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10505
City
Stockton
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10514
City
Centennial
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10503
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10499
City
Lawrenceville
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10474
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10490
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10498
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10509
City
Dekalb
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 10493
City
Normal
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 10486
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Teva Investigational Site 10494
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Teva Investigational Site 10515
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 10540
City
Traverse City
State/Province
Michigan
Country
United States
Facility Name
Teva Investigational Site 10513
City
Columbia
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 10532
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Teva Investigational Site 10507
City
Brick
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 10534
City
Corning
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10492
City
Cortland
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10517
City
Niagara Falls
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10482
City
Rochester
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10535
City
Watertown
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10478
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10516
City
Holly Springs
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10485
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10480
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10500
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10529
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10537
City
Ashland
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10527
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10502
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10477
City
Blue Bell
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10484
City
Upland
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10511
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Teva Investigational Site 10497
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10521
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10528
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Teva Investigational Site 10483
City
Boerne
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10489
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10520
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10476
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10491
City
Kerrville
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10487
City
Plano
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10501
City
Plano
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10523
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10531
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10539
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10475
City
Waco
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10488
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 10506
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 10510
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 10519
City
Burke
State/Province
Virginia
Country
United States
Facility Name
Teva Investigational Site 10481
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Teva Investigational Site 10533
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26115578
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.
Results Reference
derived

Learn more about this trial

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

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