Seasonal Allergic RhinitisPhase 2NCT01753739
Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)
A Phase 2 study testing Bepotastine besilate in people with Seasonal Allergic Rhinitis, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Bepotastine besilate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 617 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2013
- Phase
- Phase 2
- 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
- The subject is a male or female 12 years of age or older.
- Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1.
- Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test.
- Have a minimum rTNSS of at least 6 units for the morning (AM) assessment on the day of Visit 2 and Visit 3.
- Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
- Have a minimum stuffy nose score of at least 2 units on the day of Visit 3.
- Have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
- Have at least one score ≥ 2 units at Visit 3 of any of the RQLQ(S) questions #4-#6 regarding sleep.
Who cannot join
- Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit 2.
- Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist.
- Is participating or have participated in any investigational drug or device study within 30 days preceding Visit 2.
- Have had nasal or sinus surgery within 12 weeks of Visit 2.
- Have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (IP).
- For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Irvine, California, 92618-2301
About this study
Official title: A Dose-Ranging Study to Evaluate the Safety and Efficacy of Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) in Subjects With a Demonstrated History of Mountain Cedar Pollen Allergic Sensitivity
This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Bepotastine besilate, Placebo
- 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.
Bepotastine besilateDrug
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
PlaceboDrug
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Bepotastine besilate Concentration 1 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. Receives: Drug: Bepotastine besilate |
| Placebo | Active comparator | Placebo nasal spray BID for 14 days Receives: Drug: Placebo |
| Bepotastine besilate Concentration 2 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. Receives: Drug: Bepotastine besilate |
| Bepotastine besilate Concentration 3 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. Receives: Drug: Bepotastine besilate |
| Bepotastine besilate Concentration 4 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. Receives: Drug: Bepotastine besilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.
Measured: 14 Days
Secondary outcomes (2)
Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS)
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms.
Measured: 14 Days
Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms.
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionMay 2013
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Williams, Ph.D., Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753739
- Sponsor's protocol ID
- 823
- Status last verified
- Oct 2020
- First submitted
- 18 Dec 2012
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study to Evaluate the Safety and Efficacy of Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) in Subjects With a Demonstrated History of Mountain Cedar Pollen Allergic Sensitivity
- ClinicalTrials.gov ID
- NCT01753739
- Acronym / sponsor ID
- 823
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 14 Sep 2020
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 examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bepotastine besilate Concentration 1 | Experimental | Drug: Bepotastine besilateBepotastine besilate nasal spray, BID for 14 days. |
| Placebo | Active comparator | Drug: PlaceboPlacebo nasal spray BID for 14 days |
| Bepotastine besilate Concentration 2 | Experimental | Drug: Bepotastine besilateBepotastine besilate nasal spray, BID for 14 days. |
| Bepotastine besilate Concentration 3 | Experimental | Drug: Bepotastine besilateBepotastine besilate nasal spray, BID for 14 days. |
| Bepotastine besilate Concentration 4 | Experimental | Drug: Bepotastine besilateBepotastine besilate nasal spray, BID for 14 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is a male or female 12 years of age or older.
- Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1.
- Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test.
- Have a minimum rTNSS of at least 6 units for the morning (AM) assessment on the day of Visit 2 and Visit 3.
- Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
Key exclusion criteria (6 listed)
- Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit 2.
- Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist.
- Is participating or have participated in any investigational drug or device study within 30 days preceding Visit 2.
- Have had nasal or sinus surgery within 12 weeks of Visit 2.
- Have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (IP).
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 |
|---|---|---|
| Bepotastine besilateNasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days | Drug | Bepotastine besilate Concentration 1, Bepotastine besilate Concentration 2, Bepotastine besilate Concentration 3, Bepotastine besilate Concentration 4 |
| PlaceboNasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days | Drug | Placebo |
Primary outcome
Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
Time frame: 14 Days
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.
2 secondary outcomes
Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS)
Time frame: 14 Days
Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
Time frame: 14 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon Williams, Ph.D. study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bepotastine besilate in people with Seasonal Allergic Rhinitis, run by Bausch & Lomb Incorporated at 1 site 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 8 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 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Sep 2020). 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?
Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) (time frame: 14 Days). 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 5 Oct 2020.