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

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)

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Drug: Beclomethasone dipropionate; Drug: Placebo Nasal Aerosol

• Study Type: Interventional
• Enrollment (Actual): 529
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Oxford, Alabama, United States, 36203
      • Teva Clinical Sudy Site
  • California
    • 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
      • Teva Clinical Study Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Teva Clinical Study Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Teva Clinical Study Site
    • Stockbridge, Georgia, United States, 30281
      • Teva Clinical Study Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • Teva Clinical Study Site
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Teva Clinical Study Site
    • Overland Park, Kansas, United States, 66210
      • Teva Clinical Study Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Teva Clinical Study Site
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Teva Clinical Study Site
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Teva Clinical Study Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Teva Clinical Study Site
    • Plymouth, Minnesota, United States, 55441
      • Teva Clinical Study Site
  • Montana
    • Bozeman, Montana, United States, 59718
      • Teva Clinical Study Site
  • New York
    • 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
      • Teva Clinical Study Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Teva Clinical Study Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Teva Clinical Study Site
    • Sylvania, Ohio, United States, 43560
      • Teva Clinical Study Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Teva Clinical Study Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18020
      • Teva Clinical Study Site
    • Collegeville, Pennsylvania, United States, 19426
      • Teva Clinical Study Site
  • Texas
    • 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
      • Teva Clinical Study Site
  • Washington
    • Vancouver, Washington, United States, 98664
      • Teva Clinical Study Site
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Teva Clinical Study Site
    • West Allis, Wisconsin, United States, 53227
      • Teva Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks	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.	Baseline (Days -6 to 0), Day 1 to Week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks	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.	Baseline (Days -6 to 0), Day 1 to Week 30
Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks	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.	Baseline (Days -6 to 0), Day 1 to Week 52
Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks	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.	Baseline (Days -6 to 0), Day 1 to Week 52
Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline	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.	Day 0 (Baseline) and Week 30
Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline	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.	Day 0 (Baseline) and Week 52

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Study Director, Teva Branded

Publications and helpful links

General Publications

• Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, 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 May-Jun;33(3):249-57. doi: 10.2500/aap.2012.33.3571.
• 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.
• 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 once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol. J Allergy Clin Immunol 2012 (Supplement); 129:AB188 - 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
• Weinstein SF, Andrews CP, Shah SR, Chylack LT Jr, Tankelevich A, Ding Y, Tantry SK. Long-term efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol. Allergy Asthma Proc. 2014 Jul-Aug;35(4):323-31. doi: 10.2500/aap.2014.35.3767.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2009
• Primary Completion (ACTUAL): February 28, 2011
• Study Completion (ACTUAL): February 28, 2011

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (ESTIMATE): October 2, 2009

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Hay fever; Allergic rhinitis; Rhinitis, Allergic, Perennial; BDP-HFA
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: BDP-AR-303