Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis

NCT01632540 | Completed

• 1 other identifier: BDP-AR-401
• Study Type: observational
• Target: 824
• Locations: 1 country
• Sites: 46

Brief Summary

This study will be a prospective observational study of "real world" BDP nasal aerosol users with PAR, with or without seasonal allergic rhinitis (SAR). Subjects will respond to monthly online surveys regarding rhinitis control, concomitant medical conditions, concomitant (non-AR) medications, current AR therapy, and adverse events.

Conditions

Perennial Allergic Rhinitis (PAR)

Outcome Measures

Primary Outcomes (1)

• Change in Rhinitis Control Assessment Test (RCAT) Score

  The RCAT will be completed each month and uses a one-week recall period. This questionnaire has six items that ask about nasal and other allergy symptoms and the control of these symptoms. Each question is responded to on a scale of 1-5. The responses are summed to evaluate a total score. A higher score (22-30) indicates that symptoms are well controlled. A lower score (5-21) indicates that rhinitis symptoms are not well controlled.

  Baseline and 6 months

Secondary Outcomes (6)

• Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score

  Baseline and 6 months

• Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score

  Baseline and 6 months

• Change in the Pittsburgh Sleep Quality Index (PSQI) score

  Baseline and 6 months

• Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score

  Baseline and 6 months

• Change in overall healthcare utilization

  Baseline and 6 months

Study Arms (1)

Perennial Allergic Rhinitis patients

Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol

Interventions

Beclomethasone Dipropionate (BDP) Nasal Aerosol DRUG

BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.

Also known as: QNASL

Perennial Allergic Rhinitis patients

Eligibility Criteria

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

Study Population

Male and female patients, at least 12 years of age, with a diagnosis of PAR for at least one year and who are newly prescribed BDP nasal aerosol.

You may qualify if:

• Male or female
• Age 12 years or greater at time of enrollment
• Diagnosis of PAR for at least one year; and 2)a positive skin prick (ie, epicutaneous) or serum-specific IgE test within the past 2 years to a perennial allergen as appropriate for the location; and 3)PAR symptoms that are consistent with exposure to this allergen for at least one year
• Uncontrolled rhinitis symptoms at the time of assessment as confirmed by a score of 21 or less on the RCAT
• Newly prescribed BDP Nasal Aerosol (within the past 7 days but have not yet used)
• Willing and able to complete surveys in English on a computer with internet access
• Willing and able to provide informed consent prior to entering the study (or parent/caregiver/legal guardian if applicable)

You may not qualify if:

• Current acute or chronic sinusitis or chronic purulent nasal discharge
• Rhinitis medicamentosa or nasal structural abnormalities (including nasal polyps and clinically significant septal deviation) that significantly interfere with nasal airflow
• Acute upper respiratory infection within the past 14 days
• Used any pressurized metered-dose inhaler INS product (including BDP Nasal Aerosol and Ciclesonide Nasal Aerosol) within the past 90 days
• Used any experimental therapy for AR within the past 30 days
• Any condition which the investigator feels may interfere with the study

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• United BioSource, LLC: collaborator

Study Sites (46)

Teva Investigational Site 024

Little Rock, Alaska, United States

Location

Teva Investigational Site 028

Phoenix, Arizona, United States

Location

Teva Investigational Site 003

Encinitas, California, United States

Location

Teva Investigational Site 042

Fresno, California, United States

Location

Teva Investigational Site 006

Los Angeles, California, United States

Location

Teva Investigational Site 017

Orange, California, United States

Location

Teva Investigational Site 007

Palmdale, California, United States

Location

Teva Investigational Site 021

Paramount, California, United States

Location

Teva Investigational Site 040

Redwood City, California, United States

Location

Teva Investigational Site 014

Tallahassee, Florida, United States

Location

Teva Investigational Site 010

Tamarac, Florida, United States

Location

Teva Investigational Site 038

Albany, Georgia, United States

Location

Teva Investigational Site 031

Lawrenceville, Georgia, United States

Location

Teva Investigational Site 035

Savannah, Georgia, United States

Location

Teva Investigational Site 043

Fort Mitchell, Kentucky, United States

Location

Teva Investigational Site 034

Owensboro, Kentucky, United States

Location

Teva Investigational Site 033

Mandeville, Louisiana, United States

Location

Teva Investigational Site 004

Bethesda, Maryland, United States

Location

Teva Investigational Site 037

Novi, Michigan, United States

Location

Teva Investigational Site 026

Omaha, Nebraska, United States

Location

Teva Investigational Site 002

Brick, New Jersey, United States

Location

Teva Investigational Site 019

Corning, New York, United States

Location

Teva Investigational Site 018

New York, New York, United States

Location

Teva Investigational Site 039

Niagara Falls, New York, United States

Location

Teva Investigational Site 011

High Point, North Carolina, United States

Location

Teva Investigational Site 027

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 030

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 013

Toledo, Ohio, United States

Location

Teva Investigational Site 022

Ashland, Oregon, United States

Location

Teva Investigational Site 016

Eugene, Oregon, United States

Location

Teva Investigational Site 032

Havertown, Pennsylvania, United States

Location

Teva Investigational Site 025

Normal Square, Pennsylvania, United States

Location

Teva Investigational Site 012

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 023

Upland, Pennsylvania, United States

Location

Teva Investigational Site 015

Dallas, Texas, United States

Location

Teva Investigational Site 029

Dallas, Texas, United States

Location

Teva Investigational Site 009

Fort Worth, Texas, United States

Location

Teva Investigational Site 020

Houston, Texas, United States

Location

Teva Investigational Site 041

San Antonio, Texas, United States

Location

Teva Investigational Site 044

San Antonio, Texas, United States

Location

Teva Investigational Site 046

San Antonio, Texas, United States

Location

Teva Investigational Site 001

Waco, Texas, United States

Location

Teva Investigational Site 005

Murray, Utah, United States

Location

Teva Investigational Site 045

Newport News, Virginia, United States

Location

Teva Investigational Site 008

Puyallup, Washington, United States

Location

Teva Investigational Site 036

Greenfield, Wisconsin, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Beclomethasone; alpha-ketoisovalerate dehydrogenase phosphatase; Nasal Sprays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mark Lepore, MD

  Teva Pharmaceutical Industries, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 3, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

US (46)