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Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

NCT00854360•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Male or female patients 12 years of age and 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 patient at increased risk during the study.
•A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR 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 be exposed to the allergen and require treatment throughout the entire study period.
•A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
•Other criteria apply

Exclusion Criteria

•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 physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
•History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
•Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
•Other criteria apply

Locations (26)

Teva Global Respiratory Research Study Site

Mission Viejo, California, United States

Teva Global Respiratory Research Study Site

San Diego, California, United States

Teva Global Respiratory Research Study Site

San Diego, California, United States

Teva Global Respiratory Research Study Site

Colorado Springs, Colorado, United States

Teva Global Respiratory Research Study Site

Denver, Colorado, United States

Teva Global Respiratory Research Study Site

Gainesville, Georgia, United States

Teva Global Respiratory Research Study Site

Savannah, Georgia, United States

Teva Global Respiratory Research Study Site

Indianapolis, Indiana, United States

Teva Global Respiratory Research Study Site

Overland Park, Kansas, United States

Teva Global Respiratory Research Study Site

Bethesda, Maryland, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

May 1, 2009

Completion Date

May 1, 2009

Last Updated

May 22, 2012

Enrollment

487

ACTUAL participants

Conditions

Seasonal Allergic RhinitisHayfever

Interventions

Beclomethasone dipropionate HFA Nasal Aerosol

DRUG

Placebo

DRUG

Sponsors

Lead Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

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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: May 22, 2012Data 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.

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