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

NCT ID: NCT01783548

Last Updated: 2015-10-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

BDP Nasal Aerosol

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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BDP Nasal Aerosol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Beclomethasone dipropionate QNASL®

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Teva Investigational Site 10522

Hot Springs, Arkansas, United States

Site Status

Teva Investigational Site 10518

Costa Mesa, California, United States

Site Status

Teva Investigational Site 10526

Downey, California, United States

Site Status

Teva Investigational Site 10496

Huntington Beach, California, United States

Site Status

Teva Investigational Site 10536

Huntington Beach, California, United States

Site Status

Teva Investigational Site 10479

Mission Viejo, California, United States

Site Status

Teva Investigational Site 10524

Orange, California, United States

Site Status

Teva Investigational Site 10508

Paramount, California, United States

Site Status

Teva Investigational Site 10495

San Diego, California, United States

Site Status

Teva Investigational Site 10504

San Diego, California, United States

Site Status

Teva Investigational Site 10505

Stockton, California, United States

Site Status

Teva Investigational Site 10514

Centennial, Colorado, United States

Site Status

Teva Investigational Site 10503

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 10499

Lawrenceville, Georgia, United States

Site Status

Teva Investigational Site 10474

Savannah, Georgia, United States

Site Status

Teva Investigational Site 10490

Stockbridge, Georgia, United States

Site Status

Teva Investigational Site 10498

Stockbridge, Georgia, United States

Site Status

Teva Investigational Site 10509

DeKalb, Illinois, United States

Site Status

Teva Investigational Site 10493

Normal, Illinois, United States

Site Status

Teva Investigational Site 10486

Indianapolis, Indiana, United States

Site Status

Teva Investigational Site 10494

Louisville, Kentucky, United States

Site Status

Teva Investigational Site 10515

North Dartmouth, Massachusetts, United States

Site Status

Teva Investigational Site 10540

Traverse City, Michigan, United States

Site Status

Teva Investigational Site 10513

Columbia, Missouri, United States

Site Status

Teva Investigational Site 10532

Missoula, Montana, United States

Site Status

Teva Investigational Site 10507

Brick, New Jersey, United States

Site Status

Teva Investigational Site 10534

Corning, New York, United States

Site Status

Teva Investigational Site 10492

Cortland, New York, United States

Site Status

Teva Investigational Site 10517

Niagara Falls, New York, United States

Site Status

Teva Investigational Site 10482

Rochester, New York, United States

Site Status

Teva Investigational Site 10535

Watertown, New York, United States

Site Status

Teva Investigational Site 10478

High Point, North Carolina, United States

Site Status

Teva Investigational Site 10516

Holly Springs, North Carolina, United States

Site Status

Teva Investigational Site 10485

Canton, Ohio, United States

Site Status

Teva Investigational Site 10480

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 10500

Cleveland, Ohio, United States

Site Status

Teva Investigational Site 10529

Middleburg Heights, Ohio, United States

Site Status

Teva Investigational Site 10537

Ashland, Oregon, United States

Site Status

Teva Investigational Site 10527

Medford, Oregon, United States

Site Status

Teva Investigational Site 10502

Portland, Oregon, United States

Site Status

Teva Investigational Site 10477

Blue Bell, Pennsylvania, United States

Site Status

Teva Investigational Site 10484

Upland, Pennsylvania, United States

Site Status

Teva Investigational Site 10511

Warwick, Rhode Island, United States

Site Status

Teva Investigational Site 10497

Charleston, South Carolina, United States

Site Status

Teva Investigational Site 10521

Orangeburg, South Carolina, United States

Site Status

Teva Investigational Site 10528

Knoxville, Tennessee, United States

Site Status

Teva Investigational Site 10483

Boerne, Texas, United States

Site Status

Teva Investigational Site 10489

Dallas, Texas, United States

Site Status

Teva Investigational Site 10520

Dallas, Texas, United States

Site Status

Teva Investigational Site 10476

El Paso, Texas, United States

Site Status

Teva Investigational Site 10491

Kerrville, Texas, United States

Site Status

Teva Investigational Site 10487

Plano, Texas, United States

Site Status

Teva Investigational Site 10501

Plano, Texas, United States

Site Status

Teva Investigational Site 10523

San Antonio, Texas, United States

Site Status

Teva Investigational Site 10531

San Antonio, Texas, United States

Site Status

Teva Investigational Site 10539

San Antonio, Texas, United States

Site Status

Teva Investigational Site 10475

Waco, Texas, United States

Site Status

Teva Investigational Site 10488

Salt Lake City, Utah, United States

Site Status

Teva Investigational Site 10506

Salt Lake City, Utah, United States

Site Status

Teva Investigational Site 10510

Salt Lake City, Utah, United States

Site Status

Teva Investigational Site 10519

Burke, Virginia, United States

Site Status

Teva Investigational Site 10481

Richmond, Virginia, United States

Site Status

Teva Investigational Site 10533

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26115578 (View on PubMed)

Other Identifiers

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BDP-AR-306

Identifier Type: -

Identifier Source: org_study_id

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