Perennial Allergic Rhinitis (PAR)BALANCENCT01632540
Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis
An observational study of Perennial Allergic Rhinitis (PAR), run by Teva Branded Pharmaceutical Products R&D, Inc. at 46 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis (PAR)
- What is being tested?
- Beclomethasone Dipropionate (BDP) Nasal Aerosol
- How many people
- 824 participants
- Where
- 46 sitesUnited States
- Study dates
- Jul 2012to Feb 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Teva Investigational Site 038
Albany, Georgia
Teva Investigational Site 022
Ashland, Oregon
Teva Investigational Site 004
Bethesda, Maryland
Teva Investigational Site 002
Brick, New Jersey
Teva Investigational Site 019
Corning, New York
Teva Investigational Site 015
Dallas, Texas
Teva Investigational Site 029
Dallas, Texas
Teva Investigational Site 003
Encinitas, California
Teva Investigational Site 016
Eugene, Oregon
Teva Investigational Site 043
Fort Mitchell, Kentucky
Teva Investigational Site 009
Fort Worth, Texas
Teva Investigational Site 042
Fresno, California
Teva Investigational Site 036
Greenfield, Wisconsin
Teva Investigational Site 032
Havertown, Pennsylvania
Teva Investigational Site 011
High Point, North Carolina
Teva Investigational Site 020
Houston, Texas
Teva Investigational Site 031
Lawrenceville, Georgia
Teva Investigational Site 024
Little Rock, Alaska
Teva Investigational Site 006
Los Angeles, California
Teva Investigational Site 033
Mandeville, Louisiana
Teva Investigational Site 005
Murray, Utah
Teva Investigational Site 018
New York, New York
Teva Investigational Site 045
Newport News, Virginia
Teva Investigational Site 039
Niagara Falls, New York
Teva Investigational Site 025
Normal Square, Pennsylvania
Teva Investigational Site 037
Novi, Michigan
Teva Investigational Site 026
Omaha, Nebraska
Teva Investigational Site 017
Orange, California
Teva Investigational Site 034
Owensboro, Kentucky
Teva Investigational Site 007
Palmdale, California
Teva Investigational Site 021
Paramount, California
Teva Investigational Site 028
Phoenix, Arizona
Teva Investigational Site 012
Pittsburgh, Pennsylvania
Teva Investigational Site 008
Puyallup, Washington
Teva Investigational Site 040
Redwood City, California
Teva Investigational Site 041
San Antonio, Texas
Teva Investigational Site 044
San Antonio, Texas
Teva Investigational Site 046
San Antonio, Texas
Teva Investigational Site 035
Savannah, Georgia
Teva Investigational Site 014
Tallahassee, Florida
Teva Investigational Site 010
Tamarac, Florida
Teva Investigational Site 013
Toledo, Ohio
Teva Investigational Site 023
Upland, Pennsylvania
Teva Investigational Site 001
Waco, Texas
Teva Investigational Site 027
Winston-Salem, North Carolina
Teva Investigational Site 030
Winston-Salem, North Carolina
About this study
Official title: Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients
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)
- Being tested
- Beclomethasone Dipropionate (BDP) Nasal Aerosol
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone Dipropionate (BDP) Nasal AerosolDrug
Also called QNASL
BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.
| Study group | Role | What they receive |
|---|---|---|
| Perennial Allergic Rhinitis patients | Not described Receives: Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (6)
Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score
The TSQM-9 asks patients about their level of satisfaction or dissatisfaction with the medication they are taking in the study. The 3 subscales (effectiveness, convenience, global satisfaction) are rated separately, and there is no overall score. 7 questions have responses ranging from 1=extremely dissatisfied/difficult/inconvenient to 7=extremely satisfied/easy/convenient. 2 questions have responses ranging from 1=not at all confident/certain to 5=extremely confident/certain. Higher scores indicate greater satisfaction with the medication.
Measured: Baseline and 6 months
Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score
The WPAI-CIQ-AS is a 9-item, patient-reported scale that asks about the amount of time lost from work or academic classes due to allergies, as well as the impact of allergies on performing work in the workplace or in school or attending classes. It also asks about the effect of allergies on other usual daily activities. All questions ask for recall of the last 7 days. Outcomes are expressed as impairment percentages, with higher scores indicating greater impairment and less productivity.
Measured: Baseline and 6 months
Change in the Pittsburgh Sleep Quality Index (PSQI) score
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month interval. 19 items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction. The scores of these components yield a "global score". A global score of 5 or greater indicates a poor sleeper.
Measured: Baseline and 6 months
Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score
This 14-item scale covers 5 domains: activity limitations, practical problems, nose symptoms, eye symptoms, other symptoms. Responses range from 0=not troubled to 6=extremely troubled. 5 component scores and a global score are calculated. Higher scores indicate being more troubled as a result of nose/eye symptoms during the past week.
Measured: Baseline and 6 months
Change in overall healthcare utilization
Medical resources include in-patient care (hospitalizations, days of hospitalization), emergency room, and out-patient visits to physicians and other healthcare providers. The health services utilization survey asks for a 3 month recall and will be completed at baseline and months 3, 6, 9, and 12.
Measured: Baseline and 6 months
Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic Rhinitis (PAR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 824 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC
- Responsible party
- Sponsor
- Investigators
- Mark Lepore, MD, Principal investigator, Teva Pharmaceutical Industries, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632540
- Sponsor's protocol ID
- BDP-AR-401
- Acronym
- BALANCE
- Status last verified
- Apr 2014
- First submitted
- 28 Jun 2012
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients
- ClinicalTrials.gov ID
- NCT01632540
- Acronym / sponsor ID
- BALANCE / BDP-AR-401
- Conditions
- Perennial Allergic Rhinitis (PAR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United BioSource, LLC
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perennial Allergic Rhinitis patients | – | Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclomethasone Dipropionate (BDP) Nasal AerosolAlso: QNASLBDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily. | Drug | Perennial Allergic Rhinitis patients |
Primary outcome
Change in Rhinitis Control Assessment Test (RCAT) Score
Time frame: Baseline and 6 months
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.
6 secondary outcomes
Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score
Time frame: Baseline and 6 months
Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score
Time frame: Baseline and 6 months
Change in the Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Baseline and 6 months
Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score
Time frame: Baseline and 6 months
Change in overall healthcare utilization
Time frame: Baseline and 6 months
Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR)
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lepore, MD principal investigator
Teva Pharmaceutical Industries, Ltd.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perennial Allergic Rhinitis (PAR), run by Teva Branded Pharmaceutical Products R&D, Inc. at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rhinitis Control Assessment Test (RCAT) Score (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.