Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Olopatadine HCL Nasal Spray, 0.6%

Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily

Group Type EXPERIMENTAL

Olopatadine HCL Nasal Spray, 0.6%

Intervention Type DRUG

Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily

Fluticasone Propionate Nasal Spray, 50 mcg

Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate Nasal Spray, 50 mcg

Intervention Type DRUG

Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Interventions

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Olopatadine HCL Nasal Spray, 0.6%

Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily

Intervention Type DRUG

Fluticasone Propionate Nasal Spray, 50 mcg

Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A history of spring/summer seasonal allergies.
* Positive skin prick test for the currently prevalent allergen of the area.
* Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
* For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.

Exclusion:

* History of chronic sinusitis.
* Asthma, with the exception of intermittent asthma.
* Smokers.
* Known non-responders to antihistamines.
* Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
* Chronic use of long acting antihistamines.
* Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
* Relatives of study site staff or other individuals who had access to the clinical study protocol.
* Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes