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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01134705
Other study ID # BDP-AR-302
Secondary ID
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


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
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