Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 Mcg in Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00988247
First received: September 30, 2009
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a "dry" nasal aerosol which may be preferred by some patients.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
Drug: Beclomethasone dipropionate
Drug: Placebo Nasal Aerosol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Long-term Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 30 ] [ Designated as safety issue: No ]

    Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:

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

    The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.



Secondary Outcome Measures:
  • Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 30 ] [ Designated as safety issue: No ]

    Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:

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

    The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.


  • Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 52 ] [ Designated as safety issue: No ]

    Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:

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

    The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.


  • Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 52 ] [ Designated as safety issue: No ]

    Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:

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

    The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement.


  • Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [ Time Frame: Day 0 (Baseline) and Week 30 ] [ Designated as safety issue: No ]

    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.

    Week 30 scores were compared to baseline scores. A negative change score indicates improvement.


  • Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [ Time Frame: Day 0 (Baseline) and Week 52 ] [ Designated as safety issue: No ]

    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.

    Week 52 scores were compared to baseline scores. A negative change score indicates improvement.



Enrollment: 529
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDP HFA 320 µg/day
During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.
Drug: Beclomethasone dipropionate
Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 30-weeks (or 52-weeks, depending upon investigator site).
Other Name: QNASL(TM)
Placebo Comparator: Placebo
During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Drug: Placebo Nasal Aerosol
Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, 12 years of age or older as of the Screening Visit (SV)
  • General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study
  • A history of PAR to a relevant perennial allergen for a minimum of two years immediately preceding the study Screening Visit (SV). The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past, and in the investigator's judgment is expected to require treatment throughout the entire study
  • A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the diluent control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (SV) is acceptable
  • 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, including nasal piercing, or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to Screening Visit [SV])
  • Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study
  • 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 β-agonists and any controller drugs (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.
  • Other criteria apply

Randomization Criteria

  • Subject continues to be in general good health, meeting the selection criteria
  • Subject has a minimum subject-reported reflective TNSS of an average of 5 (out of a possible 12) on the last 7 days during the Run-In Period
  • The subject-reported scores for rhinorrhea or nasal congestion must be an average of 2 or greater during the last 7 days of the Run-In Period
  • Each subject must have adequately completed the electronic AR Assessment Diary (failure is defined as missing the diary entry on more than 2 calendar days during the last 7 days of the Run-In Period)
  • Other criteria apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988247

  Hide Study Locations
Locations
United States, Alabama
Teva Clinical Sudy Site
Oxford, Alabama, United States, 36203
United States, California
Teva Clinical Study Site
Encinitas, California, United States, 92024
Teva Clinical Study Site
Huntington Beach, California, United States, 92647
Teva Clinical Study Site
San Diego, California, United States, 92120
Teva Clinical Study Site
Stockton, California, United States, 95207
United States, Colorado
Teva Clinical Study Site
Colorado Springs, Colorado, United States, 80907
United States, Georgia
Teva Clinical Study Site
Atlanta, Georgia, United States, 30342
Teva Clinical Study Site
Stockbridge, Georgia, United States, 30281
United States, Illinois
Teva Clinical Study Site
Normal, Illinois, United States, 61761
United States, Kansas
Teva Clinical Study Site
Lenexa, Kansas, United States, 66215
Teva Clinical Study Site
Overland Park, Kansas, United States, 66210
United States, Louisiana
Teva Clinical Study Site
Metairie, Louisiana, United States, 70006
United States, Maryland
Teva Clinical Study Site
Wheaton, Maryland, United States, 20902
United States, Michigan
Teva Clinical Study Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Teva Clinical Study Site
Minneapolis, Minnesota, United States, 55402
Teva Clinical Study Site
Plymouth, Minnesota, United States, 55441
United States, Montana
Teva Clinical Study Site
Bozeman, Montana, United States, 59718
United States, New York
Teva Clinical Study Site
North Syracuse, New York, United States, 13212
Teva Clinical Study Site
Rochester, New York, United States, 14618
Teva Clinical Study Site
Rockville Center, New York, United States, 11570
United States, North Carolina
Teva Clinical Study Site
High Point, North Carolina, United States, 27262
United States, Ohio
Teva Clinical Study Site
Cincinnati, Ohio, United States, 45231
Teva Clinical Study Site
Sylvania, Ohio, United States, 43560
United States, Oregon
Teva Clinical Study Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Teva Clinical Study Site
Bethlehem, Pennsylvania, United States, 18020
Teva Clinical Study Site
Collegeville, Pennsylvania, United States, 19426
United States, Texas
Teva Clinical Study Site
Dallas, Texas, United States, 75231
Teva Clinical Study Site
El Paso, Texas, United States, 79903
Teva Clinical Study Site
Houston, Texas, United States, 77054
Teva Clinical Study Site
Kerrville, Texas, United States, 78028
Teva Clinical Study Site
San Antonio, Texas, United States, 78229
United States, Washington
Teva Clinical Study Site
Vancouver, Washington, United States, 98664
United States, Wisconsin
Teva Clinical Study Site
Greenfield, Wisconsin, United States, 53228
Teva Clinical Study Site
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Study Director Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

Publications:
Meltzer EO, Jacobs RL, LaForce CF, Kelley L, Dunbar SA, Tantry SK. Safety and Efficacy of Once Daily Treatment With beclomethasone dipropionate nasal aerosol in Subjects With Perennial Allergic Rhinitis. Allergy Asthma Proc (2012) (E-Pub)
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 2011 (Supplement); 107(11):A118 - Poster presentation.
Gross GN, Settipane RA, Ford LB, Kelley L, Dunbar SA, Tantry SK, Dorinsky PM . Patient Satisfaction and Ease-of-Use of BDP HFA Nasal Aerosol Device in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol 2011 (Supplement); 107(11):A119 - Poster presentation

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00988247     History of Changes
Other Study ID Numbers: BDP-AR-303
Study First Received: September 30, 2009
Results First Received: April 23, 2012
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Rhinitis, Allergic, Perennial
BDP-HFA
Hay fever
Allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014