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NCT01578278 · ClinicalTrials.gov registry record · Phase 2
Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
A Phase 2 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 606
- Enrollment target
NCT01578278 is a Phase 2 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 606 participants.
The verdict
NCT01578278, a Phase 2 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 606 participants
- Enrollment target
Study Summary
This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.
Interventions
- DRUG Placebo Comparator
- DRUG Fluticasone propionate
- DRUG Bepotastine besilate formulation
- DRUG Bepotastine besilate-fluticasone propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01578278
The ClinicalTrials.gov registry entry for NCT01578278 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 606 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo Comparator is the first listed.
NCT01578278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01578278 about?
NCT01578278 is a clinical study titled "Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis". This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary st...
What is the current status of trial NCT01578278?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 606 participants. The study started on 2011-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01578278?
The interventions under investigation include: Placebo Comparator (DRUG), Fluticasone propionate (DRUG), Bepotastine besilate formulation (DRUG), Bepotastine besilate-fluticasone propionate (DRUG).
Who is sponsoring clinical trial NCT01578278?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
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