Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691665
• Other study ID #: SMA-08-06
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2008
• Last updated: March 23, 2010
• Start date: May 2008

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Olopatadine HCL Nasal Spray, 0.6%
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
• Fluticasone Propionate Nasal Spray, 50 mcg
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Locations

Country	Name	City	State
United States	Sacramento, CA	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline	Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.	14 Days minus baseline	No
Primary	Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline	Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.	14 days minus baseline	No
Primary	Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline	Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.	14 Days minus baseline	No
Primary	Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline	Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.	14 Days minus baseline	No