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

NCT01134705 | Completed Phase 3 Results

• 1 other identifier: BDP-AR-302
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 35

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.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

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

  Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)

• Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  Baseline and Week 6

Study Arms (2)

BDP HFA 320 µg/day

EXPERIMENTAL

During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.

Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Nasal Aerosol

Interventions

Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol DRUG

Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol

Also known as: QNASL(TM)

BDP HFA 320 µg/day

Placebo Nasal Aerosol DRUG

HFA Vehicle Aerosol

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (35)

Teva Clinical Study Site

Los Angeles, California, 90025, United States

Location

Teva Clinical Study Site

Mission Viejo, California, 92691, United States

Location

Teva Clinical Study Site

San Diego, California, 92123, United States

Location

Teva Clinical Study Site

San Jose, California, 95117, United States

Location

Teva Clinical Study Site

Miami, Florida, 33173, United States

Location

Teva Clinical Study Site

Tallahassee, Florida, 32308, United States

Location

Teva Clinical Study Site

Lilburn, Georgia, 30047, United States

Location

Teva Clinical Study Site

Indianapolis, Indiana, 46208, United States

Location

Teva Clinical Study Site

Bangor, Maine, 04401, United States

Location

Teva Clinical Study Site

Bethesda, Maryland, 20814, United States

Location

Teva Clinical Study Site

Rolla, Missouri, 65401, United States

Location

Teva Clinical Study Site

St Louis, Missouri, 63141, United States

Location

Teva Clinical Study Site

Brick, New Jersey, 08724, United States

Location

Teva Clinical Study Site

Raleigh, North Carolina, 27607, United States

Location

Teva Clinical Study Site

Winston-Salem, North Carolina, 27103, United States

Location

Teva Clinical Study Site

Canton, Ohio, 44718, United States

Location

Teva Clinical Study Site

Medford, Oregon, 97504, United States

Location

Teva Clinical Study Site

Portland, Oregon, 97213, United States

Location

Teva Clinical Study Site

Blue Bell, Pennsylvania, 19422, United States

Location

Teva Clinical Study Site

Upland, Pennsylvania, 19013, United States

Location

Teva Clinical Study Site

Providence, Rhode Island, 02906, United States

Location

Teva Clinical Study Site

Charleston, South Carolina, 29407, United States

Location

Teva Clinical Study Site

Spartanburg, South Carolina, 29303, United States

Location

Teva Clinical Study Site

Austin, Texas, 78731, United States

Location

Teva Clinical Study Site

Dallas, Texas, 75230, United States

Location

Teva Clinical Study Site

Dallas, Texas, 75231, United States

Location

Teva Clinical Study Site

Fort Worth, Texas, 76132, United States

Location

Teva Clinical Study Site

Katy, Texas, 77450, United States

Location

Teva Clinical Study Site

New Braunfels, Texas, 78130, United States

Location

Teva Clinical Study Site

San Antonio, Texas, 78229, United States

Location

Teva Clinical Study Site

San Antonio, Texas, 78829, United States

Location

Teva Clinical Study Site

Waco, Texas, 76712, United States

Location

Teva Clinical Study Site

Newport News, Virginia, 23606, United States

Location

Teva Clinical Study Site

Richmond, Virginia, 23233, United States

Location

Teva Clinical Study Site

Bellevue, Washington, 68123, United States

Location

Related Publications (6)

• 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.

  RESULT

• 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.

  RESULT

• 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

  RESULT

• 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.

  PMID: 24169062 DERIVED

• 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.

  PMID: 23026182 DERIVED

• 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.

  PMID: 22737708 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Sudeesh Tantry, Ph.D.

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: June 2, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 23, 2012
• Results First Posted: May 23, 2012

Record last verified: 2012-04

Locations

US (35)