Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

Alcon

Status and phase: Completed; Phase 4

Conditions: Vasomotor Rhinitis

Treatments: Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%; Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00979615

SMA-09-03

Details and patient eligibility

About

The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).

Enrollment: 129 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis
• Negative skin tests to a panel of allergens and positive histamine test within last 2 years
• History of symptoms related to defined VMR triggers

Exclusion criteria

• Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications
• Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit
• Chronic use of drugs that can cause rhinitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 2 patient groups

1

Experimental group

Description:

Olopatadine HCL Nasal Spray, 0.6%

Treatment:

Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%

2

Active Comparator group

Description:

Azelastine HCl Nasal Spray, 137 mcg

Treatment:

Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg