Phase 4
N=129
Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
Vasomotor Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00979615 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Mean Change in 2-week rTNSS From Baseline — 5.9; 6.5 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olopatadine HCL (Patanase) Nasal Spray, 0.6% (Drug); Azelastine HCl (Astelin) Nasal Spray, 137 mcg (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in 2-week rTNSS From Baseline |
5.9; 6.5 | — |
| SECONDARY Mean Change in Rhinorrhea Reflective Score |
1.5; 1.3 | — |
| SECONDARY Mean Change Postnasal Drip Reflective Score |
1.5; 1.8 | — |
| SECONDARY Mean Change Nasal Congestion Reflective Score |
1.4; 1.7 | — |
| SECONDARY Mean Change in Sneezing Reflective Score |
1.4; 1.7 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00979615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.