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Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Long-term Efficacy and Safety of BDP HFA Nasal Aerosol (320 mcg, Once Daily) in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)

NCT00988247•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a "dry" nasal aerosol which may be preferred by some patients.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects, 12 years of age or older as of the Screening Visit (SV)
•General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study
•A history of PAR to a relevant perennial allergen for a minimum of two years immediately preceding the study Screening Visit (SV). The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past, and in the investigator's judgment is expected to require treatment throughout the entire study
•A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the diluent control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (SV) is acceptable
•Other criteria apply

Exclusion Criteria

•History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, including nasal piercing, or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to Screening Visit \[SV\])
•Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study
•History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis, or influenza within the 14 days preceding the Screening Visit (SV) or development of a respiratory infection during the Run-In Period
•Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists and any controller drugs (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable.
•Other criteria apply
•Randomization Criteria
•Subject continues to be in general good health, meeting the selection criteria
•Subject has a minimum subject-reported reflective TNSS of an average of 5 (out of a possible 12) on the last 7 days during the Run-In Period
•The subject-reported scores for rhinorrhea or nasal congestion must be an average of 2 or greater during the last 7 days of the Run-In Period
•Each subject must have adequately completed the electronic AR Assessment Diary (failure is defined as missing the diary entry on more than 2 calendar days during the last 7 days of the Run-In Period)
+1 more criteria

Locations (34)

Teva Clinical Sudy Site

Oxford, Alabama, United States

Teva Clinical Study Site

Encinitas, California, United States

Teva Clinical Study Site

Huntington Beach, California, United States

Teva Clinical Study Site

San Diego, California, United States

Teva Clinical Study Site

Stockton, California, United States

Teva Clinical Study Site

Colorado Springs, Colorado, United States

Teva Clinical Study Site

Atlanta, Georgia, United States

Teva Clinical Study Site

Stockbridge, Georgia, United States

Teva Clinical Study Site

Normal, Illinois, United States

Teva Clinical Study Site

Lenexa, Kansas, United States

Key Dates

Start Date

October 31, 2009

Primary Completion Date

February 28, 2011

Completion Date

February 28, 2011

Last Updated

December 3, 2021

Enrollment

529

ACTUAL participants

Conditions

Rhinitis, Allergic, Perennial

Interventions

Beclomethasone dipropionate

DRUG

Placebo Nasal Aerosol

DRUG

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

NCT00779545

Rhinitis, Allergic, Perennial

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COMPLETEDPHASE3

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

NCT00406783

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

Inclusion Criteria

Exclusion Criteria

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

Single Dosing Clinical Trial of HL151

Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)