Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

Overview

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 perennial allergic rhinitis.

Full Title of Study: “Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2010

Interventions

  • Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
    • Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
  • Drug: Placebo Nasal Aerosol
    • HFA Vehicle Aerosol

Arms, Groups and Cohorts

  • Experimental: BDP HFA 320 µg/day
    • During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
  • Placebo Comparator: Placebo
    • During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
    • Time Frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
    • Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.

Secondary Measures

  • Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period
    • Time Frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
    • Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (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 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
    • Time Frame: Baseline and Week 6
    • 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. A negative change from Baseline score indicates improvement.

Participating in This Clinical Trial

Inclusion Criteria

  • Informed Consent – Documented history of perennial allergic rhinitis – A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. – Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12) – 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 or during the run-in period – Use of any prohibited concomitant medications

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Teva Branded Pharmaceutical Products R&D, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sudeesh Tantry, Ph.D., Study Director, Teva Branded Pharmaceutical Products R&D, Inc.

Citations Reporting on Results

Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK (2011). 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. 107(11):A118.

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 (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

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