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

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
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 Rhinitis, Allergic, Perennial

Eligibility Criteria

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

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

Sites / Locations

  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study 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 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.

During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Outcomes

Primary Outcome Measures

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-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 Outcome Measures

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-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)
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.

Full Information

First Posted
May 27, 2010
Last Updated
April 23, 2012
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01134705
Brief Title
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
Official Title
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
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 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 perennial allergic rhinitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
BDP HFA 320 µg/day
Arm Type
Experimental
Arm Description
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
Intervention Type
Drug
Intervention Name(s)
Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
Other Intervention Name(s)
QNASL(TM)
Intervention Description
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Intervention Type
Drug
Intervention Name(s)
Placebo Nasal Aerosol
Intervention Description
HFA Vehicle Aerosol
Primary Outcome Measure Information:
Title
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
Description
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.
Time Frame
Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Secondary Outcome Measure Information:
Title
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period
Description
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.
Time Frame
Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Title
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Description
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.
Time Frame
Baseline and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudeesh Tantry, Ph.D.
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Clinical Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Teva Clinical Study Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Teva Clinical Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Teva Clinical Study Site
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Teva Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Teva Clinical Study Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Teva Clinical Study Site
City
Lilburn
State/Province
Georgia
ZIP/Postal Code
30047
Country
United States
Facility Name
Teva Clinical Study Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
Teva Clinical Study Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Teva Clinical Study Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Teva Clinical Study Site
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Teva Clinical Study Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Teva Clinical Study Site
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Teva Clinical Study Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Teva Clinical Study Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Teva Clinical Study Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Teva Clinical Study Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Teva Clinical Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Teva Clinical Study Site
City
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
Teva Clinical Study Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Teva Clinical Study Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Teva Clinical Study Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Teva Clinical Study Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Teva Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Teva Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Teva Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Teva Clinical Study Site
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Teva Clinical Study Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Teva Clinical Study Site
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Teva Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Teva Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78829
Country
United States
Facility Name
Teva Clinical Study Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Teva Clinical Study Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Teva Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Teva Clinical Study Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
68123
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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
Results Reference
result
PubMed Identifier
24169062
Citation
Meltzer EO, Korenblat PE, Lanier BQ, Kelley L, Tantry SK. Beclomethasone dipropionate nasal aerosol with an integrated dose counter: functionality and performance. Allergy Asthma Proc. 2013 Nov-Dec;34(6):534-41. doi: 10.2500/aap.2013.34.3707.
Results Reference
derived
PubMed Identifier
23026182
Citation
Nayak AS, Atiee GJ, Dige E, Maloney J, Nolte H. Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):404-10. doi: 10.2500/aap.2012.33.3605. Erratum In: Allergy Asthma Proc. 2012 Nov-Dec;33(6):499.
Results Reference
derived
PubMed Identifier
22737708
Citation
Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, 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 May-Jun;33(3):249-57. doi: 10.2500/aap.2012.33.3571.
Results Reference
derived

Learn more about this trial

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

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