Back to resultsComparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olopatadine HCL Nasal Spray, 0.6%
Fluticasone Propionate Nasal Spray, 50 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Rhinitis, Seasonal Allergic Rhinitis, allergies
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.
Sites / Locations
- Sacramento, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Olopatadine HCL Nasal Spray, 0.6%
Fluticasone Propionate Nasal Spray, 50 mcg
Arm Description
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00691665
Brief Title
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Rhinitis, Seasonal Allergic Rhinitis, allergies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olopatadine HCL Nasal Spray, 0.6%
Arm Type
Experimental
Arm Description
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
Arm Title
Fluticasone Propionate Nasal Spray, 50 mcg
Arm Type
Active Comparator
Arm Description
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Intervention Type
Drug
Intervention Name(s)
Olopatadine HCL Nasal Spray, 0.6%
Intervention Description
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate Nasal Spray, 50 mcg
Intervention Description
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Primary Outcome Measure Information:
Title
Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
Description
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.
Time Frame
14 Days minus baseline
Title
Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline
Description
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.
Time Frame
14 days minus baseline
Title
Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
Description
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.
Time Frame
14 Days minus baseline
Title
Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
Description
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.
Time Frame
14 Days minus baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Sacramento, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
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