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Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

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ClinicalTrials.gov Identifier: NCT00854360
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : May 22, 2012
Last Update Posted : May 22, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:
This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Hayfever Drug: Beclomethasone dipropionate HFA Nasal Aerosol Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 487 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
Study Start Date : March 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: BDP HFA 80 µg/day
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily.
 Drug: Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Other Name: QNASL(TM)

Drug: Placebo
HFA Vehicle Aerosol
Experimental: BDP HFA 160 µg/day
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
 Drug: Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Other Name: QNASL(TM)
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.
 Drug: Beclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
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.
 Drug: Placebo
HFA Vehicle Aerosol


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period [ Time Frame: Baseline (Day -6 to 0) and Days 1-15 (2-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, 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 the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.



Secondary Outcome Measures :
  1. Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period [ Time Frame: Baseline (Day -6 to 0) and Days 1-15 (2-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 the 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 symptom, bothersome but tolerable); 3=severe (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.


  2. Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period [ Time Frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period) ]
    Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). 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.

  3. Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: Baseline and Week 2 ]
    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 symptom improvement.

  4. Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period [ Time Frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period) ]

    Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale:

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

    The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement.


  5. Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period [ Time Frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period) ]

    Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale:

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

    Total non-nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female patients 12 years of age and 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 patient at increased risk during the study.
  • A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR 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 be exposed to the allergen and require treatment throughout the entire study period.
  • A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
  • Other criteria apply

Key Exclusion Criteria:

  • 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 physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
  • History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
  • Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
  • Other criteria apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854360


Locations
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United States, California
Teva Global Respiratory Research Study Site
Mission Viejo, California, United States, 92691
Teva Global Respiratory Research Study Site
San Diego, California, United States, 92120
Teva Global Respiratory Research Study Site
San Diego, California, United States, 92123
United States, Colorado
Teva Global Respiratory Research Study Site
Colorado Springs, Colorado, United States, 08907
Teva Global Respiratory Research Study Site
Denver, Colorado, United States, 08230
United States, Georgia
Teva Global Respiratory Research Study Site
Gainesville, Georgia, United States, 030501
Teva Global Respiratory Research Study Site
Savannah, Georgia, United States, 31406
United States, Indiana
Teva Global Respiratory Research Study Site
Indianapolis, Indiana, United States, 46208
United States, Kansas
Teva Global Respiratory Research Study Site
Overland Park, Kansas, United States, 66210
United States, Maryland
Teva Global Respiratory Research Study Site
Bethesda, Maryland, United States, 20814
United States, Missouri
Teva Global Respiratory Research Study Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
Teva Global Respiratory Research Study Site
Brick, New Jersey, United States, 08724
United States, North Carolina
Teva Global Respiratory Research Study Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Teva Global Respiratory Research Study Site
Medford, Oregon, United States, 97504
Teva Global Respiratory Research Study Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
Teva Global Respiratory Research Study Site
Blue Bell, Pennsylvania, United States, 19422
Teva Global Respiratory Research Study Site
Pittsburgh, Pennsylvania, United States, 15241
Teva Global Respiratory Research Study Site
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Teva Global Respiratory Research Study Site
Charleston, South Carolina, United States, 29407
United States, Texas
Teva Global Respiratory Research Study Site
Austin, Texas, United States, 78713
Teva Global Respiratory Research Study Site
Dallas, Texas, United States, 75231
Teva Global Respiratory Research Study Site
New Braunfels, Texas, United States, 78130
Teva Global Respiratory Research Study Site
San Antonio, Texas, United States, 78229
United States, Utah
Teva Global Respiratory Research Study Site
Draper, Utah, United States, 84020
United States, Virginia
Teva Global Respiratory Research Study Site
Burke, Virginia, United States, 22015
Teva Global Respiratory Research Study Site
Richmond, Virginia, United States, 23233
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Chair: Sudeesh Tantry, Ph.D. Teva Branded Pharmaceutical Products R&D, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT00854360    
Other Study ID Numbers: BDP-AR-201
First Posted: March 3, 2009    Key Record Dates
Results First Posted: May 22, 2012
Last Update Posted: May 22, 2012
Last Verified: April 2012
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Seasonal Allergic Rhinitis
Hayfever
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents