Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

April 23, 2012 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

474

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
    • California
      • Los Angeles, California, United States, 90025
        • Teva Clinical Study Site
      • Mission Viejo, California, United States, 92691
        • Teva Clinical Study Site
      • San Diego, California, United States, 92123
        • Teva Clinical Study Site
      • San Jose, California, United States, 95117
        • Teva Clinical Study Site
    • Florida
      • Miami, Florida, United States, 33173
        • Teva Clinical Study Site
      • Tallahassee, Florida, United States, 32308
        • Teva Clinical Study Site
    • Georgia
      • Lilburn, Georgia, United States, 30047
        • Teva Clinical Study Site
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Teva Clinical Study Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Teva Clinical Study Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Teva Clinical Study Site
    • Missouri
      • Rolla, Missouri, United States, 65401
        • Teva Clinical Study Site
      • St. Louis, Missouri, United States, 63141
        • Teva Clinical Study Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Teva Clinical Study Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Teva Clinical Study Site
      • Winston Salem, North Carolina, United States, 27103
        • Teva Clinical Study Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Teva Clinical Study Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Teva Clinical Study Site
      • Portland, Oregon, United States, 97213
        • Teva Clinical Study Site
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • Teva Clinical Study Site
      • Upland, Pennsylvania, United States, 19013
        • Teva Clinical Study Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Teva Clinical Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Teva Clinical Study Site
      • Spartanburg, South Carolina, United States, 29303
        • 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, 75231
        • Teva Clinical Study Site
      • Ft. Worth, Texas, United States, 76132
        • Teva Clinical Study Site
      • Katy, Texas, United States, 77450
        • Teva Clinical Study Site
      • New Braunfels, Texas, United States, 78130
        • Teva Clinical Study Site
      • San Antonio, Texas, United States, 78229
        • Teva Clinical Study Site
      • San Antonio, Texas, United States, 78829
        • Teva Clinical Study Site
      • Waco, Texas, United States, 76712
        • Teva Clinical Study Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Teva Clinical Study Site
      • Richmond, Virginia, United States, 23233
        • Teva Clinical Study Site
    • Washington
      • Bellevue, Washington, United States, 68123
        • 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed Consent
  • Documented history of perennial allergic rhinitis
  • A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
  • Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
  • Other criteria apply

Exclusion Criteria:

  • History of physical findings of nasal pathology (within 60 days prior to screening visit)
  • Participation in any investigational drug study 30 days preceding screening visit
  • History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
  • Use of any prohibited concomitant medications

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BDP HFA 320 µg/day
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Other Names:
  • QNASL(TM)
Placebo Comparator: Placebo
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
Drug: Placebo Nasal Aerosol
HFA Vehicle Aerosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
Time Frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)

Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:

0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).

The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period
Time Frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)

Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale:

0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).

The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time Frame: Baseline and Week 6
The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.
Baseline and Week 6

Collaborators and Investigators

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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Director: Sudeesh Tantry, Ph.D., 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

May 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDP-AR-302

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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