Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

February 3, 2015 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

715

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Oxford, Alabama, United States, 36203
        • Teva Clinical Study Site
    • California
      • Bell, California, United States, 90201
        • Teva Clinical Study Site
      • Costa Mesa, California, United States, 92626
        • Teva Clinical Study Site
      • Mission Viejo, California, United States, 92691
        • Teva Clinical Study Site
      • Orange, California, United States, 92868
        • Teva Clinical Study Site
      • Paramount, California, United States, 90723
        • Teva Clinical Study Site
      • San Diego, California, United States, 92123
        • Teva Clinical Study Site
      • San Diego, California, United States, 92120
        • Teva Clinical Study Site
      • Stockton, California, United States, 95207
        • Teva Clinical Study Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Teva Clinical Study Site
      • Colorado Springs, Colorado, United States, 80907
        • Teva Clinical Study Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Teva Clinical Study Site
      • Lawrenceville, Georgia, United States, 30046
        • Teva Clinical Study Site
      • Savannah, Georgia, United States, 31406
        • Teva Clinical Study Site
      • Stockbridge, Georgia, United States, 30281
        • Teva Clinical Study Site
    • Indiana
      • Indianapolis, Indiana, United States, 43208
        • Teva Clinical Study Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Teva Clinical Study Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Teva Clinical Study Site
      • Plymouth, Minnesota, United States, 55441
        • Teva Clinical Study Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Teva Clinical Study Site
      • Rolla, Missouri, United States, 65401
        • Teva Clinical Study Site
      • Warrensburg, Missouri, United States, 64093
        • Teva Clinical Study Site
    • Montana
      • Bozeman, Montana, United States, 597158
        • Teva Clinical Study Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Teva Clinical Study Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Teva Clinical Study Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Teva Clinical Study Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Teva Clinical Study Site
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • Teva Clinical Study Site
      • Collegeville, Pennsylvania, United States, 19426
        • Teva Clinical Study Site
      • Philadelphia, Pennsylvania, United States, 19115
        • Teva Clinical Study Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Teva Clinical Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 20460
        • Teva Clinical Study Site
      • Orangeburg, South Carolina, United States, 29119
        • Teva Clinical Study Site
    • Texas
      • Austin, Texas, United States, 78731
        • Teva Clinical Study Site
      • Dallas, Texas, United States, 75230
        • Teva Clinical Study Site
      • Dallas, Texas, United States, 75246
        • Teva Clinical Study Site
      • El Paso, Texas, United States, 79903
        • Teva Clinical Study Site
      • Ft. Worth, Texas, United States, 76132
        • Teva Clinical Study Site
      • Houston, Texas, United States, 77054
        • Teva Clinical Study Site
      • Kerrville, Texas, United States, 78028
        • Teva Clinical Study Site
      • New Braunfels, Texas, United States, 78130
        • Teva Clinical Study Site
      • San Antonio, Texas, United States, 78229
        • Teva Clinical Study Site
      • Waco, Texas, United States, 76712
        • Teva Clinical Study Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • Teva Clinical Study Site
      • Richmond, Virginia, United States, 23233
        • Teva Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)
  • A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
  • A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR 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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BDP HFA 80 mcg/day
Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
Drug: BDP HFA
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
Other Names:
  • BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) Nasal Aerosol
  • QNASL®
EXPERIMENTAL: BDP HFA 160 mcg/day
Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
Drug: BDP HFA
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
Other Names:
  • BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) Nasal Aerosol
  • QNASL®
PLACEBO_COMPARATOR: Placebo nasal aerosol once daily
Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Drug: Placebo nasal aerosol
Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.

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) During the Two Weeks of Treatment
Time Frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

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 was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

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) During the Two Weeks of Treatment
Time Frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

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 was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization.
Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (ESTIMATE)

March 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDP-AR-305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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