Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01134705
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : May 23, 2012
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol Drug: Placebo Nasal Aerosol Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134705


Locations
Layout table for location information
United States, California
Teva Clinical Study Site
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
United States, Florida
Teva Clinical Study Site
Miami, Florida, United States, 33173
Teva Clinical Study Site
Tallahassee, Florida, United States, 32308
United States, Georgia
Teva Clinical Study Site
Lilburn, Georgia, United States, 30047
United States, Indiana
Teva Clinical Study Site
Indianapolis, Indiana, United States, 46208
United States, Maine
Teva Clinical Study Site
Bangor, Maine, United States, 04401
United States, Maryland
Teva Clinical Study Site
Bethesda, Maryland, United States, 20814
United States, Missouri
Teva Clinical Study Site
Rolla, Missouri, United States, 65401
Teva Clinical Study Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
Teva Clinical Study Site
Brick, New Jersey, United States, 08724
United States, North Carolina
Teva Clinical Study Site
Raleigh, North Carolina, United States, 27607
Teva Clinical Study Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Teva Clinical Study Site
Canton, Ohio, United States, 44718
United States, Oregon
Teva Clinical Study Site
Medford, Oregon, United States, 97504
Teva Clinical Study Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
Teva Clinical Study Site
Blue Bell, Pennsylvania, United States, 19422
Teva Clinical Study Site
Upland, Pennsylvania, United States, 19013
United States, Rhode Island
Teva Clinical Study Site
Providence, Rhode Island, United States, 02906
United States, South Carolina
Teva Clinical Study Site
Charleston, South Carolina, United States, 29407
Teva Clinical Study Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Teva Clinical Study Site
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
United States, Virginia
Teva Clinical Study Site
Newport News, Virginia, United States, 23606
Teva Clinical Study Site
Richmond, Virginia, United States, 23233
United States, Washington
Teva Clinical Study Site
Bellevue, Washington, United States, 68123
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
Layout table for investigator information
Study Director: Sudeesh Tantry, Ph.D. Teva Branded Pharmaceutical Products R&D, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK (2011). BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol (Supplement); 107(11):A118 - Poster presentation.
Carr W, Meltzer EO, Finn A, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. Effective nasal symptom relief and improvement in health-related quality of life in subjects with perennial allergic rhinitis following 6-week

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT01134705    
Other Study ID Numbers: BDP-AR-302
First Posted: June 2, 2010    Key Record Dates
Results First Posted: May 23, 2012
Last Update Posted: May 23, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents