Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01024608
First received: December 2, 2009
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Hay Fever
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, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Hydrofluoroalkane (BDP HFA) Nasal Aerosol in Subjects 12 Years of Age and Older With SAR

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ] [ Designated as safety issue: No ]

    Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:

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

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



Secondary Outcome Measures:
  • Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ] [ Designated as safety issue: No ]

    Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale:

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

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


  • Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [ Time Frame: Day 0 (Baseline), Day 15 ] [ Designated as safety issue: No ]
    The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.

  • Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period [ Time Frame: Baseline (Days -3 to 0), and Days 1-15 ] [ Designated as safety issue: No ]

    Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:

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

    The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement.



Enrollment: 340
Study Start Date: December 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDP HFA 320 µg/day
During the 2-week 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 two weeks.
Other Name: QNASL(TM)
Placebo Comparator: Placebo
During the 2-week 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 each morning for two weeks.

  Eligibility

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

Inclusion Criteria:

  • Informed Consent
  • Male or female subjects 12 years of age or older
  • Documented history of season allergic rhinitis to mountain cedar pollen
  • General good health
  • Other criteria apply

Exclusion Criteria:

  • History of physical findings of nasal pathology (within 60 days prior to screening visit)
  • Participation in any investigational drug study 30 days preceding screening visit
  • History of respiratory infection/disorder with 14 days preceding screening visit
  • Use of any prohibited concomitant medications
  • Other criteria apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024608

Locations
United States, Texas
Teva Clinical Trial Site
Austin, Texas, United States, 78731
Teva Clinical Trial Site
New Braunfels, Texas, United States, 78130
Teva Clinical Trial Site
San Antonio, Texas, United States, 78229
Teva Clinical Trial Site
Waco, Texas, United States, 76712
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Sudeesh Tantry, Ph.D. Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

Publications:
Van Bavel J, Ratner PH, Amar NJ, Hampel FC, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily Effectively Improves Ocular Symptoms Associated With Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
Van Bavel J, Dorinsky PM, Melchior A, Dunbar SA, and Tantry SK (2011). Nasal Symptom Relief and Improvement in Health-Related Quality of Life Following Treatment with BDP HFA Nasal Aerosol (320 mcg Once Daily) in Subjects with Seasonal Allergic Rhinitis. Allergy Asthma Proc. 32(4):330.
Van Bavel J, Hampel, FC, Ratner PH, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR). J Allergy Clin Immunol. 127(2):201.
Van Bavel J, Amar NJ, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2010).BDP HFA Nasal Aerosol, 320 mcg Once Daily, is Safe and Effective in the Treatment of Nasal Symptoms Associated with Seasonal Allergic Rhinitis (SAR). Ann Allergy Asthma Immunol. 105(5):121.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01024608     History of Changes
Other Study ID Numbers: BDP-AR-301
Study First Received: December 2, 2009
Results First Received: April 23, 2012
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
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 15, 2014