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

Rhinitis, Allergic, Perennial Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988247
• Other study ID #: BDP-AR-303
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2009
• Est. completion date: February 28, 2011

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: February 28, 2011
• Est. primary completion date: February 28, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

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).
• Placebo Nasal Aerosol
Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).

Locations

Country	Name	City	State
United States	Teva Clinical Study Site	Atlanta	Georgia
United States	Teva Clinical Study Site	Bethlehem	Pennsylvania
United States	Teva Clinical Study Site	Bozeman	Montana
United States	Teva Clinical Study Site	Cincinnati	Ohio
United States	Teva Clinical Study Site	Collegeville	Pennsylvania
United States	Teva Clinical Study Site	Colorado Springs	Colorado
United States	Teva Clinical Study Site	Dallas	Texas
United States	Teva Clinical Study Site	El Paso	Texas
United States	Teva Clinical Study Site	Encinitas	California
United States	Teva Clinical Study Site	Eugene	Oregon
United States	Teva Clinical Study Site	Greenfield	Wisconsin
United States	Teva Clinical Study Site	High Point	North Carolina
United States	Teva Clinical Study Site	Houston	Texas
United States	Teva Clinical Study Site	Huntington Beach	California
United States	Teva Clinical Study Site	Kerrville	Texas
United States	Teva Clinical Study Site	Lenexa	Kansas
United States	Teva Clinical Study Site	Metairie	Louisiana
United States	Teva Clinical Study Site	Minneapolis	Minnesota
United States	Teva Clinical Study Site	Normal	Illinois
United States	Teva Clinical Study Site	North Syracuse	New York
United States	Teva Clinical Study Site	Overland Park	Kansas
United States	Teva Clinical Sudy Site	Oxford	Alabama
United States	Teva Clinical Study Site	Plymouth	Minnesota
United States	Teva Clinical Study Site	Rochester	New York
United States	Teva Clinical Study Site	Rockville Center	New York
United States	Teva Clinical Study Site	San Antonio	Texas
United States	Teva Clinical Study Site	San Diego	California
United States	Teva Clinical Study Site	Stockbridge	Georgia
United States	Teva Clinical Study Site	Stockton	California
United States	Teva Clinical Study Site	Sylvania	Ohio
United States	Teva Clinical Study Site	Vancouver	Washington
United States	Teva Clinical Study Site	West Allis	Wisconsin
United States	Teva Clinical Study Site	Wheaton	Maryland
United States	Teva Clinical Study Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 beclomethason

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 -

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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