Seasonal Allergic RhinitisPhase 3NCT01024608
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
A Phase 3 study testing Beclomethasone dipropionate in people with Seasonal Allergic Rhinitis and Hay Fever, run by Teva Branded Pharmaceutical Products R&D, Inc. at 4 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 seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis, Hay Fever
- What is being tested?
- Beclomethasone dipropionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Dec 2009to 28 Feb 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
- Male or female subjects 12 years of age or older
- Documented history of season allergic rhinitis to mountain cedar pollen
- General good health
- 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
- Use of any prohibited concomitant medications
- Other criteria apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Teva Clinical Trial Site
Austin, Texas, 78731
Teva Clinical Trial Site
New Braunfels, Texas, 78130
Teva Clinical Trial Site
San Antonio, Texas, 78229
Teva Clinical Trial Site
Waco, Texas, 76712
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Hydrofluoroalkane (BDP HFA) Nasal Aerosol in Subjects 12 Years of Age and Older With SAR
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 seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis, Hay Fever
- Being tested
- Beclomethasone dipropionate, Placebo Nasal Aerosol
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone dipropionateDrug
Also called QNASL(TM)
Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.
Placebo Nasal AerosolDrug
Placebo nasal aerosol administered each morning for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| BDP HFA 320 µg/day | Experimental | During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning. Receives: Drug: Beclomethasone dipropionate |
| Placebo | Placebo comparator | During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning. 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 Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:
0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping).
The rTNSS (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 1-15
Secondary outcomes (3)
Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale:
0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).
The iTNSS (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 1-15
Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.
Measured: Day 0 (Baseline), Day 15
Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period
Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:
0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities).
The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement.
Measured: Baseline (Days -3 to 0), and Days 1-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study start31 Dec 2009
- Primary completion28 Feb 2010
- Study completion28 Feb 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 (5)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies 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
- 340 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024608
- Sponsor's protocol ID
- BDP-AR-301
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2009
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Van Bavel J, Ratner PH, Amar NJ, Hampel FC, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily Effectively Improves Ocular Symptoms Associated With Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
Van Bavel J, Dorinsky PM, Melchior A, Dunbar SA, and Tantry SK (2011). Nasal Symptom Relief and Improvement in Health-Related Quality of Life Following Treatment with BDP HFA Nasal Aerosol (320 mcg Once Daily) in Subjects with Seasonal Allergic Rhinitis. Allergy Asthma Proc. 32(4):330.
Van Bavel J, Hampel, FC, Ratner PH, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR). J Allergy Clin Immunol. 127(2):201.
Van Bavel J, Amar NJ, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2010).BDP HFA Nasal Aerosol, 320 mcg Once Daily, is Safe and Effective in the Treatment of Nasal Symptoms Associated with Seasonal Allergic Rhinitis (SAR). Ann Allergy Asthma Immunol. 105(5):121.
van Bavel JH, Ratner PH, Amar NJ, Hampel FC Jr, Melchior A, Dunbar SA, Dorinsky PM, Tantry SK. Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):386-96. doi: 10.2500/aap.2012.33.3593.
PubMed 23026180
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Hydrofluoroalkane (BDP HFA) Nasal Aerosol in Subjects 12 Years of Age and Older With SAR
- ClinicalTrials.gov ID
- NCT01024608
- Acronym / sponsor ID
- BDP-AR-301
- Conditions
- Seasonal Allergic Rhinitis, Hay Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2009 (actual)
- Primary completion
- 28 Feb 2010 (actual)
- Study completion
- 28 Feb 2010 (actual)
- First posted
- 3 Dec 2009 (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 seasonal 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 dipropionateDuring the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning. |
| Placebo | Placebo comparator | Drug: Placebo Nasal AerosolDuring the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning. |
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
- Male or female subjects 12 years of age or older
- Documented history of season allergic rhinitis to mountain cedar pollen
- General good health
- Other criteria apply
Key exclusion criteria (5 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
- Use of any prohibited concomitant medications
- Other criteria apply
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 dipropionateAlso: QNASL(TM)Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks. | Drug | BDP HFA 320 µg/day |
| Placebo Nasal AerosolPlacebo nasal aerosol administered each morning for two weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Time frame: Baseline (Days -3 to 0), and Days 1-15
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping). The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement.
3 secondary outcomes
Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Time frame: Baseline (Days -3 to 0), and Days 1-15
Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
Time frame: Day 0 (Baseline), Day 15
Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period
Time frame: Baseline (Days -3 to 0), and Days 1-15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationVan Bavel J, Ratner PH, Amar NJ, Hampel FC, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily Effectively Improves Ocular Symptoms Associated With Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
- Results publicationVan Bavel J, Dorinsky PM, Melchior A, Dunbar SA, and Tantry SK (2011). Nasal Symptom Relief and Improvement in Health-Related Quality of Life Following Treatment with BDP HFA Nasal Aerosol (320 mcg Once Daily) in Subjects with Seasonal Allergic Rhinitis. Allergy Asthma Proc. 32(4):330.
- Results publicationVan Bavel J, Hampel, FC, Ratner PH, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR). J Allergy Clin Immunol. 127(2):201.
- Results publicationVan Bavel J, Amar NJ, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2010).BDP HFA Nasal Aerosol, 320 mcg Once Daily, is Safe and Effective in the Treatment of Nasal Symptoms Associated with Seasonal Allergic Rhinitis (SAR). Ann Allergy Asthma Immunol. 105(5):121.
- Derived from this study: PubMed 23026180van Bavel JH, Ratner PH, Amar NJ, Hampel FC Jr, Melchior A, Dunbar SA, Dorinsky PM, Tantry SK. Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):386-96. doi: 10.2500/aap.2012.33.3593.
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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
4 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 in people with Seasonal Allergic Rhinitis and Hay Fever, run by Teva Branded Pharmaceutical Products R&D, Inc. at 4 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 5 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period (time frame: Baseline (Days -3 to 0), and Days 1-15). 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 NCT01024608, which also lists 5 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 3 Dec 2021.