Seasonal Allergic RhinitisPhase 1/2NCT01222299

Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

A Phase 1/2 study testing bepotastine besilate nasal product - low dose, bepotastine besilate nasal product - medium dose and bepotastine besilate nasal product - high dose 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

The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Seasonal Allergic Rhinitis
What is being tested?: bepotastine besilate nasal product - low dose, bepotastine besilate nasal product - medium dose and bepotastine besilate nasal product - high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 1 siteUnited States
Study dates: May 2010to Aug 2010
Phase: Phase 1/2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen

Who cannot join

No active respiratory tract infection

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

The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Conditions: Seasonal Allergic Rhinitis
Being tested: bepotastine besilate nasal product - low dose, bepotastine besilate nasal product - medium dose, bepotastine besilate nasal product - high dose, placebo comparator nasal product
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 product - low doseDrug
sterile nasal product
bepotastine besilate nasal product - medium doseDrug
sterile nasal product
bepotastine besilate nasal product - high doseDrug
sterile nasal product
placebo comparator nasal productDrug
sterile nasal product

Study groups in NCT01222299
Study group	Role	What they receive
Arm 1 - Low Dose	Experimental	bepotastine besilate nasal product - low dose Receives: Drug: bepotastine besilate nasal product - low dose
Arm 2 - Medium Dose	Experimental	bepotastine besilate nasal product - medium dose Receives: Drug: bepotastine besilate nasal product - medium dose
Arm 3 - High Dose	Experimental	bepotastine besilate nasal product - high dose Receives: Drug: bepotastine besilate nasal product - high dose
Arm 4 - Placebo	Placebo comparator	placebo comparator nasal product Receives: Drug: placebo comparator nasal product

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 Instantaneous TNSS
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
Measured: Baseline, 20 days

Timeline

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

May 2010Aug 2010

First posted18 Oct 2010 (estimated)
Study startMay 2010
Primary completionAug 2010
Study completionAug 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.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01222299
Sponsor's protocol ID: S00032
Status last verified: Oct 2020
First submitted: 14 Oct 2010
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

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

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, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
ClinicalTrials.gov ID: NCT01222299
Acronym / sponsor ID: S00032
Conditions: Seasonal Allergic Rhinitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 18 Oct 2010 (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.

The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Study design

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

Arm	Type	Receives
Arm 1 - Low Dose	Experimental	Drug: bepotastine besilate nasal product - low dosebepotastine besilate nasal product - low dose
Arm 2 - Medium Dose	Experimental	Drug: bepotastine besilate nasal product - medium dosebepotastine besilate nasal product - medium dose
Arm 3 - High Dose	Experimental	Drug: bepotastine besilate nasal product - high dosebepotastine besilate nasal product - high dose
Arm 4 - Placebo	Placebo comparator	Drug: placebo comparator nasal productplacebo comparator nasal product

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen

Key exclusion criteria (1 listed)

No active respiratory tract infection

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 product - low dosesterile nasal product	Drug	Arm 1 - Low Dose
bepotastine besilate nasal product - medium dosesterile nasal product	Drug	Arm 2 - Medium Dose
bepotastine besilate nasal product - high dosesterile nasal product	Drug	Arm 3 - High Dose
placebo comparator nasal productsterile nasal product	Drug	Arm 4 - Placebo

Primary outcome

Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
Time frame: Baseline, 20 days
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.

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
Placebo	21	21
Low Dose - 2%	23	21
Medium Dose - 4%	22	20
High Dose - 6%	23	18

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

Time frame: Baseline, 20 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 21	Low Dose - 2% n = 21	Medium Dose - 4% n = 20	High Dose - 6% n = 18
Day 10 (after single dose)	-1.17 (1.88)	-0.69 (2.42)	-2.43 (2.73)	-1.65 (1.95)
Day 20 (after twice daily dosing)	-1.63 (2.37)	-0.64 (2.93)	-2.52 (2.55)	-1.67 (2.22)

Population analysed: The per protocol population was based on participants who completed the study.

Adverse events

Time frame: 20 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	7 of 21 (33.3%)	0 of 21
Low Dose - 2%	0 of 23 (0%)	9 of 23 (39.1%)	0 of 23
Medium Dose - 4%	0 of 22 (0%)	9 of 22 (40.9%)	0 of 22
High Dose - 6%	0 of 23 (0%)	11 of 23 (47.8%)	0 of 23

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Instantaneous TNSS (time frame: Baseline, 20 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 NCT01222299.

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.