Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid

Alcon

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Olopatadine HCl Nasal Spray, 0.6%; Drug: Azelastine HCl Nasal Spray, 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845195

SMA-08-23

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.

Enrollment: 150 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide consent/assent
• History of spring/summer allergic rhinitis
• Positive skin prick and/or intradermal test
• Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations
• Non-pregnant (where applicable)
• Able to complete daily diary

Exclusion criteria

• Smoker
• Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps
• History of current chronic sinusitis
• Asthma
• Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines
• History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses
• History or evidence of nasolacrimal drainage system malfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Olopatadine HCl Nasal Spray, 0.6%

Experimental group

Treatment:

Drug: Olopatadine HCl Nasal Spray, 0.6%

Azelastine HCl Nasal Spray, 0.1%

Active Comparator group

Treatment:

Drug: Azelastine HCl Nasal Spray, 0.1%