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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vasomotor Rhinitis

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

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research


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).

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Change in 2-week rTNSS From Baseline

Secondary outcome:

Mean Change in Rhinorrhea Reflective Score

Mean Change Postnasal Drip Reflective Score

Mean Change Nasal Congestion Reflective Score

Mean Change in Sneezing Reflective Score


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States
Additional Information

Starting date: September 2009
Last updated: April 14, 2011

Page last updated: August 23, 2015

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