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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 Baseline

Mean 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

Page last updated: August 23, 2015

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