Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
Sponsored by: Alcon Research Overall contact:
Alcon Call Center, Phone: 1-888-451-3937
Summary
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Total Nasal VMR Symptoms Score
Secondary outcome: Individual symptom severity scores
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Alcon Call Center, Phone: 1-888-451-3937
Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States; Recruiting
Alcon Call Center
Additional Information
Starting date: September 2009
Last updated: September 17, 2009
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