Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: Olopatadine HCL Nasal Spray, 0.6% (Drug); Fluticasone Propionate Nasal Spray, 50 mcg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research
Summary
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
Clinical Details
Official title: A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From BaselineMean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sacramento, CA, Sacramento, California 95819, United States
Additional Information
Starting date: May 2008
Last updated: March 23, 2010
|