Rhinitis, Allergic, PerennialPhase 3NCT01134705
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
A Phase 3 study testing Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol in people with Rhinitis, Allergic, Perennial, run by Teva Branded Pharmaceutical Products R&D, Inc. at 35 sites in United States.
Trial summary
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 474 participants
- Where
- 35 sitesUnited States
- Study dates
- May 2010to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Informed Consent
- Documented history of perennial allergic rhinitis
- A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
- Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
- Other criteria apply
Who cannot join
- History of physical findings of nasal pathology (within 60 days prior to screening visit)
- Participation in any investigational drug study 30 days preceding screening visit
- History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
- Use of any prohibited concomitant medications
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Teva Clinical Study Site
Austin, Texas, 78731
Teva Clinical Study Site
Bangor, Maine, 04401
Teva Clinical Study Site
Bellevue, Washington, 68123
Teva Clinical Study Site
Bethesda, Maryland, 20814
Teva Clinical Study Site
Blue Bell, Pennsylvania, 19422
Teva Clinical Study Site
Brick, New Jersey, 08724
Teva Clinical Study Site
Canton, Ohio, 44718
Teva Clinical Study Site
Charleston, South Carolina, 29407
Teva Clinical Study Site
Dallas, Texas, 75230
Teva Clinical Study Site
Dallas, Texas, 75231
Teva Clinical Study Site
Fort Worth, Texas, 76132
Teva Clinical Study Site
Indianapolis, Indiana, 46208
Teva Clinical Study Site
Katy, Texas, 77450
Teva Clinical Study Site
Lilburn, Georgia, 30047
Teva Clinical Study Site
Los Angeles, California, 90025
Teva Clinical Study Site
Medford, Oregon, 97504
Teva Clinical Study Site
Miami, Florida, 33173
Teva Clinical Study Site
Mission Viejo, California, 92691
Teva Clinical Study Site
New Braunfels, Texas, 78130
Teva Clinical Study Site
Newport News, Virginia, 23606
Teva Clinical Study Site
Portland, Oregon, 97213
Teva Clinical Study Site
Providence, Rhode Island, 02906
Teva Clinical Study Site
Raleigh, North Carolina, 27607
Teva Clinical Study Site
Richmond, Virginia, 23233
Teva Clinical Study Site
Rolla, Missouri, 65401
Teva Clinical Study Site
San Antonio, Texas, 78229
Teva Clinical Study Site
San Antonio, Texas, 78829
Teva Clinical Study Site
San Diego, California, 92123
Teva Clinical Study Site
San Jose, California, 95117
Teva Clinical Study Site
Spartanburg, South Carolina, 29303
Teva Clinical Study Site
St Louis, Missouri, 63141
Teva Clinical Study Site
Tallahassee, Florida, 32308
Teva Clinical Study Site
Upland, Pennsylvania, 19013
Teva Clinical Study Site
Waco, Texas, 76712
Teva Clinical Study Site
Winston-Salem, North Carolina, 27103
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol, Placebo 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 hydrofluoroalkane HFA Nasal AerosolDrug
Also called QNASL(TM)
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Placebo Nasal AerosolDrug
HFA Vehicle Aerosol
| Study group | Role | What they receive |
|---|---|---|
| BDP HFA 320 µg/day | Experimental | During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. Receives: Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol |
| Placebo | Placebo comparator | During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. Receives: Drug: Placebo Nasal Aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).
The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Measured: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Secondary outcomes (2)
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM \& PM) using the following scale:
0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).
The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Measured: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, PerennialStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudeesh Tantry, Ph.D., Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134705
- Sponsor's protocol ID
- BDP-AR-302
- Status last verified
- Apr 2012
- First submitted
- 27 May 2010
- Last updated
- 23 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK (2011). BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol (Supplement); 107(11):A118 - Poster presentation.
Carr W, Meltzer EO, Finn A, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. Effective nasal symptom relief and improvement in health-related quality of life in subjects with perennial allergic rhinitis following 6-week
Meltzer EO, Korenblat PE, Lanier BQ, Kelley L, Tantry SK. Beclomethasone dipropionate nasal aerosol with an integrated dose counter: functionality and performance. Allergy Asthma Proc. 2013 Nov-Dec;34(6):534-41. doi: 10.2500/aap.2013.34.3707.
PubMed 24169062Nayak AS, Atiee GJ, Dige E, Maloney J, Nolte H. Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):404-10. doi: 10.2500/aap.2012.33.3605.
PubMed 23026182Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK. Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis. Allergy Asthma Proc. 2012 May-Jun;33(3):249-57. doi: 10.2500/aap.2012.33.3571.
PubMed 22737708
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)
- ClinicalTrials.gov ID
- NCT01134705
- Acronym / sponsor ID
- BDP-AR-302
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 23 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BDP HFA 320 µg/day | Experimental | Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal AerosolDuring the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. |
| Placebo | Placebo comparator | Drug: Placebo Nasal AerosolDuring the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent
- Documented history of perennial allergic rhinitis
- A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
- Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
- Other criteria apply
Key exclusion criteria (4 listed)
- History of physical findings of nasal pathology (within 60 days prior to screening visit)
- Participation in any investigational drug study 30 days preceding screening visit
- History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
- Use of any prohibited concomitant medications
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 hydrofluoroalkane HFA Nasal AerosolAlso: QNASL(TM)Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol | Drug | BDP HFA 320 µg/day |
| Placebo Nasal AerosolHFA Vehicle Aerosol | Drug | Placebo |
Primary outcome
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
Time frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
2 secondary outcomes
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period
Time frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationMeltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK (2011). BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
- Results publicationMeltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol (Supplement); 107(11):A118 - Poster presentation.
- Results publicationCarr W, Meltzer EO, Finn A, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. Effective nasal symptom relief and improvement in health-related quality of life in subjects with perennial allergic rhinitis following 6-week
- Derived from this study: PubMed 24169062Meltzer EO, Korenblat PE, Lanier BQ, Kelley L, Tantry SK. Beclomethasone dipropionate nasal aerosol with an integrated dose counter: functionality and performance. Allergy Asthma Proc. 2013 Nov-Dec;34(6):534-41. doi: 10.2500/aap.2013.34.3707.
- Derived from this study: PubMed 23026182Nayak AS, Atiee GJ, Dige E, Maloney J, Nolte H. Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):404-10. doi: 10.2500/aap.2012.33.3605.
- Derived from this study: PubMed 22737708Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK. Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis. Allergy Asthma Proc. 2012 May-Jun;33(3):249-57. doi: 10.2500/aap.2012.33.3571.
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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.
Sudeesh Tantry, Ph.D. study director
Teva Branded Pharmaceutical Products R&D, Inc.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol in people with Rhinitis, Allergic, Perennial, run by Teva Branded Pharmaceutical Products R&D, Inc. at 35 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 5 inclusion and 4 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 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period (time frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01134705, which also lists 6 linked publications.
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 23 May 2012.