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Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR
This study is ongoing, but not recruiting participants.
First Received: March 2, 2009   Last Updated: April 17, 2009   History of Changes
Sponsored by: Teva Global Respiratory Research LLC
Information provided by: Teva Global Respiratory Research LLC
ClinicalTrials.gov Identifier: NCT00854360
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Hayfever
Drug: Beclomethasone dipropionate HFA Nasal Aerosol
Drug: Placebo
Phase II

MedlinePlus related topics: Hay Fever
Drug Information available for: Beclomethasone Beclomethasone dipropionate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A 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 Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR)

Further study details as provided by Teva Global Respiratory Research LLC:

Primary Outcome Measures:
  • Average of the AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the two-week Treatment Period. [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average of AM and PM patient-reported instantaneous TNSS over the two week treatment period [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • AM patient-reported instantaneous TNSS over the two-week Treatment Period [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at Endpoint in patients with impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit (TV0) of 3.0 or greater [ Time Frame: Last visit ] [ Designated as safety issue: No ]
  • AM patient-reported 24-hour reflective ocular symptom score over the two-week Treatment Period in patients with adequate symptoms during the Run-in period [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • AM patient-reported 24-hour reflective non-nasal symptom score over the two-week Treatment Period in patients with adequate symptoms during the Run-in period [ Time Frame: Daily ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: February 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
80 mcg Total Daily Dose: Experimental Drug: Beclomethasone dipropionate HFA Nasal Aerosol
All subjects on active treatment will receive a total of 4 intranasal actuations daily from 2 separate canisters.
160 mcg Total Daily Dose: Experimental Drug: Beclomethasone dipropionate HFA Nasal Aerosol
All subjects on active treatment will receive a total of 4 intranasal actuations daily from 2 separate canisters.
320 mcg Total Daily Dose: Experimental Drug: Beclomethasone dipropionate HFA Nasal Aerosol
All subjects on active treatment will receive a total of 4 intranasal actuations daily from 2 separate canisters.
Placebo: Placebo Comparator Drug: Placebo
HFA Vehicle Aerosol

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key 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

Key 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854360

  Show 26 Study Locations
Sponsors and Collaborators
Teva Global Respiratory Research LLC
Investigators
Study Chair: Teva Global Respiratory Research Contact Teva Global Respiratory Research
  More Information

No publications provided

Responsible Party: Teva Global Respiratory Research ( Teva Global Respiratory Research Study Leader )
Study ID Numbers: BDP-AR-201
Study First Received: March 2, 2009
Last Updated: April 17, 2009
ClinicalTrials.gov Identifier: NCT00854360     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Global Respiratory Research LLC:
Seasonal Allergic Rhinitis
Hayfever

Study placed in the following topic categories:
Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Beclomethasone
Rhinitis
Glucocorticoids
Hormones
Signs and Symptoms
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Beclomethasone
Rhinitis
Hormones
Glucocorticoids
Pharmacologic Actions
Nose Diseases
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Rhinitis, Allergic, Seasonal
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 06, 2009