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

September 30, 2009
April 23, 2012
October 2009
February 2011   (final data collection date for primary outcome measure)
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.

subject-assessed 24-hour reflective Total Nasal Symptom Score (TNSS) in 52 week subjects [ Time Frame: Up to 52 weeks of the study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00988247 on ClinicalTrials.gov Archive Site
  • 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.

  • TNSS over 30 weeks [ Time Frame: Up to 30 weeks of the study ] [ Designated as safety issue: No ]
  • Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: Up to 52 weeks of the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
  • 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)
  • Drug: Placebo Nasal Aerosol
    Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).
  • 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.
    Intervention: Drug: Beclomethasone dipropionate
  • 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.
    Intervention: Drug: Placebo Nasal Aerosol
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
529
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00988247
BDP-AR-303
No
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Teva Branded Pharmaceutical Products, R&D Inc.
Not Provided
Study Director: Study Director Teva Branded Pharmaceutical Products, R&D Inc.
Teva Pharmaceutical Industries
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP