Seasonal Allergic Rhinitis
Conditions
Keywords
Rhinitis, Seasonal Allergic Rhinitis, allergies
Brief summary
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
Interventions
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
DRUGFluticasone Propionate Nasal Spray, 50 mcg
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline | 14 Days minus 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 | 14 days minus 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 | 14 Days minus 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 | 14 Days minus 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. |
Countries
United States
Participant flow
Recruitment details
Study recruitment occurred from May 14, 2008 - July 31, 2008.
Participants by arm
| Arm | Count |
|---|---|
| Olopatadine HCL Nasal Spray, 0.6% Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily | 65 |
| Fluticasone Propionate Nasal Spray, 50 Mcg Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily | 65 |
| Total | 130 |
Baseline characteristics
| Characteristic | Olopatadine HCL Nasal Spray, 0.6% | Fluticasone Propionate Nasal Spray, 50 Mcg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 2 Participants | 10 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 63 Participants | 118 Participants |
| Gender Female | 34 participants | 30 participants | 64 participants |
| Gender Male | 30 participants | 33 participants | 63 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
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.
Time frame: 14 days minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline | -45.26 Percent change | Standard Deviation 27.93 |
| Fluticasone Propionate Nasal Spray, 50 Mcg | Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline | -48.8 Percent change | Standard Deviation 30.1 |
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.
Time frame: 14 Days minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline | -36.54 Percent change | Standard Deviation 60.26 |
| Fluticasone Propionate Nasal Spray, 50 Mcg | Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline | -41.63 Percent change | Standard Deviation 50.46 |
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.
Time frame: 14 Days minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline | -45.37 Percent change | Standard Deviation 31.77 |
| Fluticasone Propionate Nasal Spray, 50 Mcg | Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline | -47.35 Percent change | Standard Deviation 32.83 |
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.
Time frame: 14 Days minus baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine HCL Nasal Spray, 0.6% | Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline | -38.52 Percent change | Standard Deviation 59.8 |
| Fluticasone Propionate Nasal Spray, 50 Mcg | Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline | -40.59 Percent change | Standard Deviation 55.66 |