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

Rhinitis, Allergic, Perennial Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134705
• Other study ID #: BDP-AR-302
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2010
• Last updated: April 23, 2012
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: April 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

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

Locations

Country	Name	City	State
United States	Teva Clinical Study Site	Austin	Texas
United States	Teva Clinical Study Site	Bangor	Maine
United States	Teva Clinical Study Site	Bellevue	Washington
United States	Teva Clinical Study Site	Bethesda	Maryland
United States	Teva Clinical Study Site	Blue Bell	Pennsylvania
United States	Teva Clinical Study Site	Brick	New Jersey
United States	Teva Clinical Study Site	Canton	Ohio
United States	Teva Clinical Study Site	Charleston	South Carolina
United States	Teva Clinical Study Site	Dallas	Texas
United States	Teva Clinical Study Site	Dallas	Texas
United States	Teva Clinical Study Site	Ft. Worth	Texas
United States	Teva Clinical Study Site	Indianapolis	Indiana
United States	Teva Clinical Study Site	Katy	Texas
United States	Teva Clinical Study Site	Lilburn	Georgia
United States	Teva Clinical Study Site	Los Angeles	California
United States	Teva Clinical Study Site	Medford	Oregon
United States	Teva Clinical Study Site	Miami	Florida
United States	Teva Clinical Study Site	Mission Viejo	California
United States	Teva Clinical Study Site	New Braunfels	Texas
United States	Teva Clinical Study Site	Newport News	Virginia
United States	Teva Clinical Study Site	Portland	Oregon
United States	Teva Clinical Study Site	Providence	Rhode Island
United States	Teva Clinical Study Site	Raleigh	North Carolina
United States	Teva Clinical Study Site	Richmond	Virginia
United States	Teva Clinical Study Site	Rolla	Missouri
United States	Teva Clinical Study Site	San Antonio	Texas
United States	Teva Clinical Study Site	San Antonio	Texas
United States	Teva Clinical Study Site	San Diego	California
United States	Teva Clinical Study Site	San Jose	California
United States	Teva Clinical Study Site	Spartanburg	South Carolina
United States	Teva Clinical Study Site	St. Louis	Missouri
United States	Teva Clinical Study Site	Tallahassee	Florida
United States	Teva Clinical Study Site	Upland	Pennsylvania
United States	Teva Clinical Study Site	Waco	Texas
United States	Teva Clinical Study Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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

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 (Sup

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)	No
Secondary	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.	Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)	No
Secondary	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.	Baseline and Week 6	No