Back to resultsComparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olopatadine HCl Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Rhinitis, Allergy, Nasal Spray, Antihistamine, Intranasal Corticosteroid
Eligibility Criteria
Inclusion Criteria:
- Able to provide consent/assent
- History of spring/summer allergic rhinitis
- Positive skin prick and/or intradermal test
- Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations
- Non-pregnant (where applicable)
- Able to complete daily diary
Exclusion Criteria:
- Smoker
- Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps
- History of current chronic sinusitis
- Asthma
- Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines
- History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses
- History or evidence of nasolacrimal drainage system malfunction
Sites / Locations
- Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Olopatadine HCl Nasal Spray, 0.6%
Azelastine HCl Nasal Spray, 0.1%
Arm Description
Outcomes
Primary Outcome Measures
Mean 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 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 Change in Instantaneous Total Nasal Symptom Scores (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 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
NCT00845195
Brief Title
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 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
The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray 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, Allergy, Nasal Spray, Antihistamine, Intranasal Corticosteroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olopatadine HCl Nasal Spray, 0.6%
Arm Type
Experimental
Arm Title
Azelastine HCl Nasal Spray, 0.1%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Olopatadine HCl Nasal Spray, 0.6%
Intervention Description
2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
Intervention Type
Drug
Intervention Name(s)
Azelastine HCl Nasal Spray, 0.1%
Intervention Description
2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
Primary Outcome Measure Information:
Title
Mean 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 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 Change in Instantaneous Total Nasal Symptom Scores (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 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
No
Eligibility Criteria
Inclusion Criteria:
Able to provide consent/assent
History of spring/summer allergic rhinitis
Positive skin prick and/or intradermal test
Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations
Non-pregnant (where applicable)
Able to complete daily diary
Exclusion Criteria:
Smoker
Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps
History of current chronic sinusitis
Asthma
Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines
History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses
History or evidence of nasolacrimal drainage system malfunction
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
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