Clinical trial NCT00988247: Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: Rhinitis, Allergic, Perennial
BDP-HFA
Hay fever
Allergic rhinitis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 529
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks
timeFrame: Baseline (Days -6 to 0), Day 1 to Week 30
Secondary outcomes:
measure: Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks
timeFrame: Baseline (Days -6 to 0), Day 1 to Week 30
measure: Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks
timeFrame: Baseline (Days -6 to 0), Day 1 to Week 52
measure: Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks
timeFrame: Baseline (Days -6 to 0), Day 1 to Week 52
measure: Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
timeFrame: Day 0 (Baseline) and Week 30
measure: Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
timeFrame: Day 0 (Baseline) and Week 52
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Teva Clinical Sudy Site
state: Alabama
city: Encinitas
country: United States
facility: Teva Clinical Study Site
state: California
city: Huntington Beach
country: United States
facility: Teva Clinical Study Site
state: California
city: San Diego
country: United States
facility: Teva Clinical Study Site
state: California
city: Stockton
country: United States
facility: Teva Clinical Study Site
state: California
city: Colorado Springs
country: United States
facility: Teva Clinical Study Site
state: Colorado
city: Atlanta
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Stockbridge
country: United States
facility: Teva Clinical Study Site
state: Georgia
city: Normal
country: United States
facility: Teva Clinical Study Site
state: Illinois
city: Lenexa
country: United States
facility: Teva Clinical Study Site
state: Kansas
city: Overland Park
country: United States
facility: Teva Clinical Study Site
state: Kansas
city: Metairie
country: United States
facility: Teva Clinical Study Site
state: Louisiana
city: Wheaton
country: United States
facility: Teva Clinical Study Site
state: Maryland
city: Ypsilanti
country: United States
facility: Teva Clinical Study Site
state: Michigan
city: Minneapolis
country: United States
facility: Teva Clinical Study Site
state: Minnesota
city: Plymouth
country: United States
facility: Teva Clinical Study Site
state: Minnesota
city: Bozeman
country: United States
facility: Teva Clinical Study Site
state: Montana
city: North Syracuse
country: United States
facility: Teva Clinical Study Site
state: New York
city: Rochester
country: United States
facility: Teva Clinical Study Site
state: New York
city: Rockville Center
country: United States
facility: Teva Clinical Study Site
state: New York
city: High Point
country: United States
facility: Teva Clinical Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Sylvania
country: United States
facility: Teva Clinical Study Site
state: Ohio
city: Eugene
country: United States
facility: Teva Clinical Study Site
state: Oregon
city: Bethlehem
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Collegeville
country: United States
facility: Teva Clinical Study Site
state: Pennsylvania
city: Dallas
country: United States
facility: Teva Clinical Study Site
state: Texas
city: El Paso
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Kerrville
country: United States
facility: Teva Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Teva Clinical Study Site
state: Texas
city: Vancouver
country: United States
facility: Teva Clinical Study Site
state: Washington
city: Greenfield
country: United States
facility: Teva Clinical Study Site
state: Wisconsin
city: West Allis
country: United States
facility: Teva Clinical Study Site
state: Wisconsin
Study officials:
affiliation: Teva Branded
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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
citation: 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.