Phase 4
N=130
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00691665 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline — -45.37; -47.35 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olopatadine HCL Nasal Spray, 0.6% (Drug); Fluticasone Propionate Nasal Spray, 50 mcg (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline |
-45.37; -47.35 | — |
| PRIMARY Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline |
-45.26; -48.8 | — |
| PRIMARY Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline |
-38.52; -40.59 | — |
| PRIMARY Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline |
-36.54; -41.63 | — |
Summary
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
Eligibility Criteria
Inclusion:
- A history of spring/summer seasonal allergies.
- Positive skin prick test for the currently prevalent allergen of the area.
- Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
- For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.
Exclusion:
- History of chronic sinusitis.
- Asthma, with the exception of intermittent asthma.
- Smokers.
- Known non-responders to antihistamines.
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
- Chronic use of long acting antihistamines.
- Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
- Relatives of study site staff or other individuals who had access to the clinical study protocol.
- Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.
Data sourced from ClinicalTrials.gov (NCT00691665). 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.