Seasonal Allergic RhinitisPhase 2NCT01277341

Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

A Phase 2 study testing Bepotastine Besilate Nasal Spray 2% Twice a day, Bepotastine Besilate Nasal Spray 3% Twice a day and Bepotastine Besilate Nasal Spray 4% Twice a day in people with Seasonal Allergic Rhinitis, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an efficacy study of bepotastine besilate nasal spray in 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
What is being tested?: Bepotastine Besilate Nasal Spray 2% Twice a day, Bepotastine Besilate Nasal Spray 3% Twice a day and Bepotastine Besilate Nasal Spray 4% Twice a day
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 601 participants
Where: 1 siteUnited States
Study dates: Dec 2010to May 2011
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

Male or female at least 12 years of age with a history of mountain cedar allergy

Who cannot join

No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

Trial locations and contacts

1 site in 1 country.

United States1 site

ISTA Pharmaceuticals, Inc.
Irvine, California, 92618

Other trials in United States

About this study

This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Conditions: Seasonal Allergic Rhinitis
Being tested: Bepotastine Besilate Nasal Spray 2% Twice a day, Bepotastine Besilate Nasal Spray 3% Twice a day, Bepotastine Besilate Nasal Spray 4% Twice a day, Placebo Nasal Spray
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 Besilate Nasal Spray 2% Twice a dayDrug
nasal spray
Bepotastine Besilate Nasal Spray 3% Twice a dayDrug
nasal spray
Bepotastine Besilate Nasal Spray 4% Twice a dayDrug
nasal spray
Placebo Nasal SprayDrug
nasal spray

Study groups in NCT01277341
Study group	Role	What they receive
2% Twice a day	Experimental	Bepotastine Besilate Nasal Spray 2% Twice a day Receives: Drug: Bepotastine Besilate Nasal Spray 2% Twice a day
3% Twice a day	Experimental	Bepotastine Besilate Nasal Spray 3% Twice a day Receives: Drug: Bepotastine Besilate Nasal Spray 3% Twice a day
4% Twice a day	Experimental	Bepotastine Besilate Nasal Spray 4% Twice a day Receives: Drug: Bepotastine Besilate Nasal Spray 4% Twice a day
Placebo	Placebo comparator	Placebo nasal spray Receives: Drug: Placebo Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline (Pre-Dose) in 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. Morning and evening scores were averaged.
Measured: Baseline, 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010May 2011

First posted14 Jan 2011 (estimated)
Study startDec 2010
Primary completionFeb 2011
Study completionMay 2011

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: 601 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01277341
Sponsor's protocol ID: S00082
Status last verified: Oct 2020
First submitted: 7 Jan 2011
Last updated: 5 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
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All Seasonal Allergic Rhinitis trials

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: Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT01277341
Acronym / sponsor ID: S00082
Conditions: Seasonal Allergic Rhinitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 601 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Feb 2011 (actual)
Study completion: May 2011 (actual)
First posted: 14 Jan 2011 (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 is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
2% Twice a day	Experimental	Drug: Bepotastine Besilate Nasal Spray 2% Twice a dayBepotastine Besilate Nasal Spray 2% Twice a day
3% Twice a day	Experimental	Drug: Bepotastine Besilate Nasal Spray 3% Twice a dayBepotastine Besilate Nasal Spray 3% Twice a day
4% Twice a day	Experimental	Drug: Bepotastine Besilate Nasal Spray 4% Twice a dayBepotastine Besilate Nasal Spray 4% Twice a day
Placebo	Placebo comparator	Drug: Placebo Nasal SprayPlacebo nasal spray

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Male or female at least 12 years of age with a history of mountain cedar allergy

Key exclusion criteria (1 listed)

No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

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 Besilate Nasal Spray 2% Twice a daynasal spray	Drug	2% Twice a day
Bepotastine Besilate Nasal Spray 3% Twice a daynasal spray	Drug	3% Twice a day
Bepotastine Besilate Nasal Spray 4% Twice a daynasal spray	Drug	4% Twice a day
Placebo Nasal Spraynasal spray	Drug	Placebo

Primary outcome

Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS
Time frame: Baseline, 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.

Results and safety

Results posted to the registry on 14 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2% Twice a Day	150	146
3% Twice a Day	150	145
4% Twice a Day	149	145
Placebo	152	146

Primary outcome: Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS

Time frame: Baseline, 14 days. Mean (Standard Deviation). Unit: score on a scale

Measure	2% Twice a Day n = 135	3% Twice a Day n = 134	4% Twice a Day n = 128	Placebo n = 130
Value	-1.84 (1.80)	-1.71 (1.97)	-1.47 (1.88)	-0.99 (1.69)

Population analysed: All randomized participants were included in the analysis population, with no imputation of missing data at 14 days.

Adverse events

Time frame: 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2% Twice a Day	0 of 150 (0%)	25 of 150 (16.7%)	0 of 150
3% Twice a Day	1 of 150 (0.7%)	22 of 150 (14.7%)	1 of 150
4% Twice a Day	0 of 149 (0%)	22 of 149 (14.8%)	0 of 149
Placebo	0 of 152 (0%)	10 of 152 (6.6%)	0 of 152

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.

Related trials for Seasonal Allergic Rhinitis

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis

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.

Tim McNamara, PharmD study director

ISTA Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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. 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 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) in Subject-rated Reflective TNSS (time frame: Baseline, 14 days). 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 NCT01277341.

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.