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Allergic RhinitisPhase 3NCT01783548

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

A Phase 3 study testing BDP Nasal Aerosol in people with Allergic Rhinitis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 63 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
BDP Nasal Aerosol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
547 participants
Where
63 sitesUnited States
Study dates
Jan 2013to Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

United States63 sites

  • Teva Investigational Site 10537

    Ashland, Oregon

  • Teva Investigational Site 10477

    Blue Bell, Pennsylvania

  • Teva Investigational Site 10483

    Boerne, Texas

  • Teva Investigational Site 10507

    Brick, New Jersey

  • Teva Investigational Site 10519

    Burke, Virginia

  • Teva Investigational Site 10485

    Canton, Ohio

  • Teva Investigational Site 10514

    Centennial, Colorado

  • Teva Investigational Site 10497

    Charleston, South Carolina

  • Teva Investigational Site 10480

    Cincinnati, Ohio

  • Teva Investigational Site 10500

    Cleveland, Ohio

  • Teva Investigational Site 10503

    Colorado Springs, Colorado

  • Teva Investigational Site 10513

    Columbia, Missouri

  • Teva Investigational Site 10534

    Corning, New York

  • Teva Investigational Site 10492

    Cortland, New York

  • Teva Investigational Site 10518

    Costa Mesa, California

  • Teva Investigational Site 10489

    Dallas, Texas

  • Teva Investigational Site 10520

    Dallas, Texas

  • Teva Investigational Site 10509

    DeKalb, Illinois

  • Teva Investigational Site 10526

    Downey, California

  • Teva Investigational Site 10476

    El Paso, Texas

  • Teva Investigational Site 10478

    High Point, North Carolina

  • Teva Investigational Site 10516

    Holly Springs, North Carolina

  • Teva Investigational Site 10522

    Hot Springs, Arkansas

  • Teva Investigational Site 10496

    Huntington Beach, California

  • Teva Investigational Site 10536

    Huntington Beach, California

  • Teva Investigational Site 10486

    Indianapolis, Indiana

  • Teva Investigational Site 10491

    Kerrville, Texas

  • Teva Investigational Site 10528

    Knoxville, Tennessee

  • Teva Investigational Site 10499

    Lawrenceville, Georgia

  • Teva Investigational Site 10494

    Louisville, Kentucky

  • Teva Investigational Site 10527

    Medford, Oregon

  • Teva Investigational Site 10529

    Middleburg Heights, Ohio

  • Teva Investigational Site 10479

    Mission Viejo, California

  • Teva Investigational Site 10532

    Missoula, Montana

  • Teva Investigational Site 10517

    Niagara Falls, New York

  • Teva Investigational Site 10493

    Normal, Illinois

  • Teva Investigational Site 10515

    North Dartmouth, Massachusetts

  • Teva Investigational Site 10524

    Orange, California

  • Teva Investigational Site 10521

    Orangeburg, South Carolina

  • Teva Investigational Site 10508

    Paramount, California

  • Teva Investigational Site 10487

    Plano, Texas

  • Teva Investigational Site 10501

    Plano, Texas

  • Teva Investigational Site 10502

    Portland, Oregon

  • Teva Investigational Site 10481

    Richmond, Virginia

  • Teva Investigational Site 10533

    Richmond, Virginia

  • Teva Investigational Site 10482

    Rochester, New York

  • Teva Investigational Site 10488

    Salt Lake City, Utah

  • Teva Investigational Site 10506

    Salt Lake City, Utah

  • Teva Investigational Site 10510

    Salt Lake City, Utah

  • Teva Investigational Site 10523

    San Antonio, Texas

  • Teva Investigational Site 10531

    San Antonio, Texas

  • Teva Investigational Site 10539

    San Antonio, Texas

  • Teva Investigational Site 10495

    San Diego, California

  • Teva Investigational Site 10504

    San Diego, California

  • Teva Investigational Site 10474

    Savannah, Georgia

  • Teva Investigational Site 10490

    Stockbridge, Georgia

  • Teva Investigational Site 10498

    Stockbridge, Georgia

  • Teva Investigational Site 10505

    Stockton, California

  • Teva Investigational Site 10540

    Traverse City, Michigan

  • Teva Investigational Site 10484

    Upland, Pennsylvania

  • Teva Investigational Site 10475

    Waco, Texas

  • Teva Investigational Site 10511

    Warwick, Rhode Island

  • Teva Investigational Site 10535

    Watertown, New York

Other trials in United States

About this study

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

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).

Being tested
BDP Nasal Aerosol, Placebo
Keywords
allergic rhinitis, pediatric subjects, BDP nasal aerosol
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BDP Nasal AerosolDrug

    Also called Beclomethasone dipropionate, QNASL®

  • PlaceboDrug

Study groups in NCT01783548
Study groupRoleWhat they receive
BDP Nasal Aerosol 80 mcg/dayExperimentalBDP 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.
Receives: Drug: BDP Nasal Aerosol
Placebo Nasal AerosolPlacebo comparatorPlacebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Secondary outcomes (3)

  1. 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.

    Measured: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

  2. 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.

    Measured: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

  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 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.

    Measured: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
547 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01783548
Sponsor's protocol ID
BDP-AR-306
Status last verified
Sep 2015
First submitted
31 Jan 2013
Last updated
12 Oct 2015
Data monitoring committee
No

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.

    PubMed 26115578

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BDP Nasal Aerosol in people with Allergic Rhinitis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01783548, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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