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

Primary Purpose

Seasonal Allergic Rhinitis, Hay Fever

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Beclomethasone dipropionate
Placebo Nasal Aerosol
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teva Clinical Trial Site
  • Teva Clinical Trial Site
  • Teva Clinical Trial Site
  • Teva Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BDP HFA 320 µg/day

Placebo

Arm Description

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.

During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.

Outcomes

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
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
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
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
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.

Full Information

First Posted
December 2, 2009
Last Updated
December 1, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01024608
Brief Title
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2009 (Actual)
Primary Completion Date
February 28, 2010 (Actual)
Study Completion Date
February 28, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis, Hay Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BDP HFA 320 µg/day
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Intervention Type
Drug
Intervention Name(s)
Beclomethasone dipropionate
Other Intervention Name(s)
QNASL(TM)
Intervention Description
Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Nasal Aerosol
Intervention Description
Placebo nasal aerosol administered each morning for two weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Description
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.
Time Frame
Baseline (Days -3 to 0), and Days 1-15
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Description
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.
Time Frame
Baseline (Days -3 to 0), and Days 1-15
Title
Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
Description
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.
Time Frame
Day 0 (Baseline), Day 15
Title
Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period
Description
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.
Time Frame
Baseline (Days -3 to 0), and Days 1-15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudeesh Tantry, Ph.D.
Organizational Affiliation
Teva Branded
Official's Role
Study Director
Facility Information:
Facility Name
Teva Clinical Trial Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Teva Clinical Trial Site
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Teva Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Teva Clinical Trial Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
23026180
Citation
van Bavel JH, Ratner PH, Amar NJ, Hampel FC Jr, Melchior A, Dunbar SA, Dorinsky PM, Tantry SK. Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):386-96. doi: 10.2500/aap.2012.33.3593.
Results Reference
derived

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

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