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
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: 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 ScoreMean Change Postnasal Drip Reflective Score Mean Change Nasal Congestion Reflective Score Mean Change in Sneezing Reflective Score
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
Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States
Additional Information
Starting date: September 2009
Last updated: April 14, 2011
|
